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					                                                            V3 Ballot Submission/Resolution Form

                             BALLOT TITLE:       HL7 Implementation Guides for CDA Release 2: IHE Health Story Consolidation, Release 1 - US Realm
                                                 (CDAR2_IG_IHE_CONSOL_R1_D1_2011MAY) - 1st DSTU Ballot


                           BALLOT CYCLE:         MAY 2011
                       SUBMITTED BY NAME:
                      SUBMITTED BY EMAIL:

                      SUBMITTED BY PHONE:
           SUBMITTED BY ORGANIZATION (if
                             applicable):
                      SUBMISSION DATE:
                SUBMITTED BY IDENTIFIER:
                   OVERALL BALLOT VOTE:




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Submitter]                                  1                                                              March 2003
                                                       V3 Ballot Submission/Resolution Form

                             BALLOT TITLE:



                           BALLOT CYCLE:
                       SUBMITTED BY NAME:
                      SUBMITTED BY EMAIL:

                      SUBMITTED BY PHONE:
           SUBMITTED BY ORGANIZATION (if
                             applicable):
                      SUBMISSION DATE:
                SUBMITTED BY IDENTIFIER:
                   OVERALL BALLOT VOTE:




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Submitter]                    2                     March 2003
                                                                  V3 Ballot Submission/Resolution Form


                                                                                Ballot Comment Submission

                                                                         Vote
                                                                         and
Ballot WG      Artifact   Artifact ID   Chapter     Section       Pubs   Type    Existing Wording                   Proposed Wording

StructDocs                                          5.27 Result          Neg-Mj 10. SHOULD contain zero or one      10. SHOULD contain zero or one
                                                    Observatio                  [0..1] interpretationCode           [0..*] interpretationCode
                                                    n                           (CONF:7147).                        (CONF:7147).




                                                    5.27 Result          Neg-Mj 6. SHOULD contain exactly one
                                                    Observatio                  [1..1] text (CONF:7138).
                                                    n                           a. element SHOULD include a
                                                                                reference element which SHOULD
                                                                                reference the narrative. The
                                                                                reference/@value SHALL begin with
                                                                                a hash '#' mark. (CONF:7139).




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                          3                                                         March 2003
                                                                  V3 Ballot Submission/Resolution Form

                                                    5.27 Result         Neg-Mj 7. SHALL contain exactly one [1..1]
                                                    Observatio                 statusCode/@code="completed"
                                                    n                          Completed




StructDocs     ??         CDAR2_IG_C Cover          Cover         Yes   Neg-Mi                                       Identify as DSTU
                          ONSOL_R1_
                          D1_2011APR
StructDocs     ??         CDAR2_IG_C All            All           No    Neg-Mj Meaningful Use                        Global replace: Stage 1 Meaningful
                          ONSOL_R1_                                                                                  Use
                          D1_2011APR
StructDocs     ??         CDAR2_IG_C 1              1.7.4         No    Neg-Mj Figures 2 and 3 Conf 2777             It would be more clear as two
                          ONSOL_R1_                                                                                  conformance statements:
                          D1_2011APR                                                                                 1.    SHALL contain exactly one
                                                                                                                     participant with exactly one
                                                                                                                     typeCode where typeCode=”LOC”
                                                                                                                     2.    MAY contain one or more
                                                                                                                     participants with exactly one
                                                                                                                     typeCode where typeCode≠”LOC”


StructDocs     ??         CDAR2_IG_C    1           1.9           No    Neg-Mj Table 1                               Add column for ballot applicability.
                          ONSOL_R1_
                          D1_2011APR
StructDocs     ??         CDAR2_IG_C    2           2.1           No    Neg-Mi Table 3
                          ONSOL_R1_
                          D1_2011APR
StructDocs     ??         CDAR2_IG_C    1           1.8.2         No     A-T     These documents to the Level 1,     These documents conform to the
                          ONSOL_R1_                                                                                  Level 1,
                          D1_2011APR
StructDocs     ??         CDAR2_IG_C    2           2.1.1         No     A-C
                          ONSOL_R1_
                          D1_2011APR




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                           4                                                               March 2003
                                                            V3 Ballot Submission/Resolution Form

StructDocs     ??         CDAR2_IG_C 2              2.1.1   No   Neg-Mj Such patientRoles SHALL contain at If the patient resides in the US, …
                          ONSOL_R1_                                     least one [1..*] US Realm Clinical
                          D1_2011APR                                    Document Header Address


StructDocs     ??         CDAR2_IG_C 2              2.1.1   No   Neg-Mi 9. This patient SHOULD contain          9. This patient SHOULD contain
                          ONSOL_R1_                                     zero or one [0..1] guardian             zero or more [0..*] guardians
                          D1_2011APR
StructDocs     ??         CDAR2_IG_C 2              2.1.1   No   Neg-Mi This guardian, if present, SHALL        This guardian, if present, SHALL
                          ONSOL_R1_                                     contain exactly one [1..1] telecom      contain exactly one or more [1..*]
                          D1_2011APR                                    (CONF:5382).                            telecom (CONF:5382).
StructDocs     ??         CDAR2_IG_C 2              2.1.1   No   Neg-Mi Table 11                                Remove
                          ONSOL_R1_
                          D1_2011APR




StructDocs     ??         CDAR2_IG_C 2              2.1.2   No   Neg-Mj The author may be a device, a           The author may be a device, a
                          ONSOL_R1_                                     person, or an organization...iv. This   person, or an organization...iv. This
                          D1_2011APR                                    assignedAuthor SHALL contain            assignedAuthor SHALL contain
                                                                        exactly one [1..1] assignedPerson       exactly one [1..1] assignedPerson if
                                                                        (CONF:5430).                            and only if the author represents a
                                                                                                                person (CONF:5430) .



StructDocs     ??         CDAR2_IG_C 2              2.1.5   No   Neg-Mj The custodian element represents the Add ress legal responsibility, i.e.,
                          ONSOL_R1_                                     entity responsible for maintaining   stewardship.
                          D1_2011APR                                    the availability of the clinical
                                                                        document
StructDocs     ??         CDAR2_IG_C 2              2.1.6   No   Neg-Mi a. Such informationRecipients, if    Fix or clarify
                          ONSOL_R1_                                     present, SHALL contain exactly one
                          D1_2011APR                                    [1..1] intendedRecipient
                                                                        (CONF:5566).
                                                                        i. This intendedRecipient MAY
                                                                        contain zero or one [0..1]
                                                                        informationRecipient (CONF:5567).


StructDocs     ??         CDAR2_IG_C 2              2.2     No   Neg-Mj The US Realm Clinical Document          The US Realm Clinical Document
                          ONSOL_R1_                                     Header Address template is used by      Header Address template is used by
                          D1_2011APR                                    US Realm Clinical Document              US Realm Clinical Document
                                                                        Header for the patient or any other     Header for the patient or any other
                                                                        person or organization mentioned        person or organization mentioned
                                                                        within it.                              within it when the represented
                                                                                                                location is in the US.



42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                    5                                                                  March 2003
                                                               V3 Ballot Submission/Resolution Form

StructDocs     ??         CDAR2_IG_C 2              2.2        No   Neg-Mi SHOULD contain @use, which       Address how to handle multiple uses
                          ONSOL_R1_                                        SHALL be selected from ValueSet… (address is home, and confidential,
                          D1_2011APR                                                                        and physical, and home office…)

StructDocs     ??         CDAR2_IG_C 2              2.2        No   Neg-Mi Table 15                                Add "HP" for primary home.
                          ONSOL_R1_
                          D1_2011APR
StructDocs     ??         CDAR2_IG_C 4              Various    No   Neg-Mj With the exceptions of Allergies and    Need to clarify how to express no
                          ONSOL_R1_                                        Meds, there are no instructions for     known items for every section. This
                          D1_2011APR                                       handling "no [procedures, results,      is explained for Allergies and Meds
                                                                           etc.] recorded."                        (an entry with a specific SNOMED
                                                                                                                   code), but not for other sections. I
                                                                                                                   suggest not requiring entries where
                                                                                                                   no correspoinding item exists. For
                                                                                                                   example, if there are no recorded
                                                                                                                   procedures, or if they have not been
                                                                                                                   coded yet, the narrative could
                                                                                                                   contain text to that effect ("No
                                                                                                                   procedures recorded for visit") and
                                                                                                                   no structured entries included.

                                                                                                                   This caused a lot of list server traffic
                                                                                                                   because the IHE profiles required
                                                                                                                   one or more entries but
                                                                                                                   implementers had no idea what to
                                                                                                                   put there.
StructDocs     ??         CDAR2_IG_C 4              4.24       No   Neg-Mj The Immunizations section defines a     Change current immunization status
                          ONSOL_R1_                                        patient‟s immunization status for the   to immunizations
                          D1_2011APR                                       context and use case of the             administered/refused during visit.
                                                                           document type. The section should       Also add context cross reference.
                                                                           include current immunization status,
                                                                           and may contain the entire
                                                                           immunization history.

StructDocs     ??         CDAR2_IG_C 3              3.3.1.10   No   Neg-Mj 3.3.1.10 Physician Reading Study
                          ONSOL_R1_                                        Performer
                          D1_2011APR                                       [participant: templateId
                                                                           2.16.840.1.113883.10.20.6.2.2(open
                                                                           )]
                                                                           This participant is the attending
                                                                           physician and is usually different
                                                                           from the Physician Reading Study
                                                                           Performer defined in
                                                                           documentationOf/serviceEvent.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                       6                                                                     March 2003
                                                               V3 Ballot Submission/Resolution Form

StructDocs     ??         CDAR2_IG_C 3              3.3.1.11   No    Neg-Mj 3.3.1.11 Physician of Record
                          ONSOL_R1_                                         Participant
                          D1_2011APR                                        [performer: templateId
                                                                            2.16.840.1.113883.10.20.6.2.1(open
                                                                            )]
                                                                            This participant is the attending
                                                                            physician and is usually different
                                                                            from the Physician Reading Study
                                                                            Performer defined in
                                                                            documentationOf/serviceEvent.
                                                                            1. SHALL contain exactly one [1..1]
                                                                            performer/@typeCode="PRF"
                                                                            (CodeSystem:
                                                                            2.16.840.1.113883.5.6
                                                                            HL7ActClass) (CONF:8424).
StructDocs     ??         CDAR2_IG_C Appendix B Appendix       No    Neg-Mj Change log not precise enough
                          ONSOL_R1_             B
                          D1_2011APR




StructDocs     ??         CDAR2_IG_C 4              4.19       Yes    A-T     Hopsital Course                     Hospital Course
                          ONSOL_R1_
                          D1_2011APR
StructDocs     ??         CDAR2_IG_C 1              1.7.6      No     A-C     Null flavors
                          ONSOL_R1_
                          D1_2011APR


StructDocs     ??         CDAR2_IG_C                General    No    Neg-Mi
                          ONSOL_R1_
                          D1_2011APR




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                        7                                          March 2003
                                                              V3 Ballot Submission/Resolution Form

StructDocs     ??         CDAR2_IG_C 3              3         No    Neg-Mi Lists five required sections for CCD Should not list any required
                          ONSOL_R1_                                                                             sections, unless qualified as a "CCD
                          D1_2011APR                                                                            conforming to Stage 1 Meaningful
                                                                                                                Use"




StructDocs     ??         CDAR2_IG_C 4              4.00      No    Neg-Mi ** wherever referenced, intent is that Should say '…or both "Assessment"
                          ONSOL_R1_                                        either “Assessment and Plan” is        and "Plan of Care."'
                          D1_2011APR                                       present or both “Assessment” and
                                                                           “Plan”. Only these combinations
                                                                           should be used.


StructDocs     ??         CDAR2_IG_C 4              4.10      No    Neg-Mj
                          ONSOL_R1_
                          D1_2011APR
StructDocs     ??         CDAR2_IG_C 4              4.18      No    Neg-Mi the Procedure History section may
                          ONSOL_R1_                                        be included under the History of
                          D1_2011APR                                       Present Illness section or it may
                                                                           stand alone as its own section.


StructDocs     ??         CDAR2_IG_C 4              4.40      No    Neg-Mi
                          ONSOL_R1_
                          D1_2011APR

StructDocs     ??         CDAR2_IG_C 4              4.49      No    Neg-Mi This section records the patient's the This section records the reason for
                          ONSOL_R1_                                        reason for the patient's visit (the    the patient's visit (the provider‟s
                          D1_2011APR                                       provider‟s description of the reason description of the reason for visit).
                                                                           for visit). Local policy determines
                                                                           whether the information is divided
                                                                           into two sections or recorded in one
                                                                           section serving both purposes.

StructDocs     ??         CDAR2_IG_C 4              4.50      No    Neg-Mi The scope includes hematology…         The scope includes observations
                          ONSOL_R1_                                                                               such as hematology…
                          D1_2011APR
StructDocs     ??         CDAR2_IG_C                General   Yes    A-S
                          ONSOL_R1_
                          D1_2011APR




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                       8                                                               March 2003
                                                              V3 Ballot Submission/Resolution Form

StructDocs     ??         CDAR2_IG_C 4              4.50      No   Neg-Mj CONF:7113 SHALL contain exactly
                          ONSOL_R1_                                       one Result organizer
                          D1_2011APR
StructDocs     ??         CDAR2_IG_C 4              4.28      No   Neg-Mi
                          ONSOL_R1_
                          D1_2011APR




StructDocs     ??         CDAR2_IG_C 4              4.35      No   Neg-Mi Plan Section                      Plan of Care Section
                          ONSOL_R1_
                          D1_2011APR
StructDocs     ??         CDAR2_IG_C 4              4.56      No   Neg-Mi CONF:7277 SHALL contain exactly
                          ONSOL_R1_                                       one Vital Signs organizer
                          D1_2011APR
StructDocs     ??         CDAR2_IG_C                General   No    A-T     SNOMEDCT, SNOMED CT,
                          ONSOL_R1_                                         SNOMED-CT
                          D1_2011APR

StructDocs     ??         CDAR2_IG_C 1              1.7.4 and No   Neg-Mi
                          ONSOL_R1_                 constraints
                          D1_2011APR                containing
                                                    "such that
                                                    it…"




StructDocs     ??         CDAR2_IG_C 5              5.20      No   Neg-Mi
                          ONSOL_R1_                 Problem
                          D1_2011APR                Status




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                    9                                             March 2003
                                                                V3 Ballot Submission/Resolution Form

StructDocs     ??         CDAR2_IG_C 1.7.2                      No   Neg-Mi
                          ONSOL_R1_ Conformance
                          D1_2011APR Statements




StructDocs     ??         CDAR2_IG_C                General     No   Neg-Mi
                          ONSOL_R1_
                          D1_2011APR




StructDocs     ??         CDAR2_IG_C 5              5.2 Alert  No    Neg-Mj
                          ONSOL_R1_                 Status
                          D1_2011APR                Observatio
                                                    n




StructDocs     ??         CDAR2_IG_C 5              5.3 Allergy No   Neg-Mj
                          ONSOL_R1_                 Problem
                          D1_2011APR                Act




StructDocs     ??         CDAR2_IG_C 5              5.5         No   Neg-Mi
                          ONSOL_R1_                 Condition
                          D1_2011APR




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                10                    March 2003
                                                              V3 Ballot Submission/Resolution Form

StructDocs     ??         CDAR2_IG_C 5              5.18       No   Neg-Mi
                          ONSOL_R1_                 Medication
                          D1_2011APR                Use - None
                                                    Known




StructDocs     ??         CDAR2_IG_C 2              2.1.1     No    Neg-Mi Such patientRoles SHALL contain         Such patientRoles SHOULD contain
                          ONSOL_R1_                                        at least one [1..*] telecom             zero or more [0..*] telecom
                          D1_2011APR                                       (CONF:5280).                            (CONF:5280).
StructDocs                                          1.7              A-C none                                      an explanation of "optional entries"
                                                                                                                   vs. "required entries"




                                                    1.7.4            A-Q     Figure 3- example of "only one like   an example that is representative
                                                                             this allowed".

                                                    2.1             Neg-Mj conformance statements only             inclusion of business names and
                                                                                                                   textual descriptions for many of the
                                                                                                                   elements. There was a draft table
                                                                                                                   format recommended by the CDA
                                                                                                                   Consolidation Documentation WG
                                                                                                                   that would significantly help.
                                                                                                                   Additional textual descriptions

                                                    2.1.2           Neg-Mj missing assignedAuthoringDevice         inclusion of these statements-
                                                                           and representedOrganization             directly or in reference




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                       11                                                                March 2003
                                                              V3 Ballot Submission/Resolution Form

                                                    2.1.7          Neg-Mi This assignedEntity SHALL contain This assignedEntity SHOULD
                                                                          exactly one assignedPerson        contain exactly one assignedPerson.
                                                                          (CONF:5597)




                                                    2.3            Neg-Mj despite the name template being for    inclusion of
                                                                          "the patient or any other person or    representedOrganization
                                                                          organization", there are not
                                                                          conformance statements for how an
                                                                          organization can be represented.

                                                    2.1            Neg-Mj no "support" / "Patient Contacts"      inclusion of template for Patient
                                                                          module equivalents                     Contacts / "Support"


                                                    2.1            Neg-Mj no "documentationOf" conformance inclusion of documentationOf
                                                                          statements                       statements



                                                    2.4            Neg-Mj no "performer" statements within       inclusion of performer statements
                                                                          serviceEvent

                                                    2.4             A-S    "use serviceEvent/effectiveTime/low
                                                                           with a width element"


                                                    3.1.1.3         A-S


                                                    3.1.2           A-T    "The Continuity of Care Document …requiring coded…
                                                                           supports both narrative sections and
                                                                           sections requiring code clinical
                                                                           statements"
                                                    3.8             A-T    "A progress Note is not a revaluation …not a re-evaluation note
                                                                           note"




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                     12                                                             March 2003
                                                           V3 Ballot Submission/Resolution Form

                                                    3.9          A-T   3rd paragraph: "…such as a word-        …"word-processing"
                                                                       proccesing document"

                                                    3.9          A-C   5th paragraph: "…more restricted        "…more restricted use case,
                                                                       use case, specifically for scanned      specifically for scanned documents
                                                                       documents, and limits…"                 or 'virtually scanned' documents
                                                                                                               (electronically created from existing
                                                                                                               text sources), and limits…"

                                                    4            A-S                                           inclusion of a description of the
                                                                                                               narrative block.

                                                    4.2          A-S   "Optional Entries"                      "Template for Entries Being
                                                                                                               optional"


                                                    4.2          A-S   "Required Entries"                      "Template for Entries Being
                                                                                                               Required"


                                                    4.5          A-S   2nd paragraph: "The assessment          delete from this paragraph or move
                                                                       formulates a specific plan or set of    to "Plan" paragraph that follows
                                                                       recommendations"
                                                    4.9          A-S   2st paragraph: "The complications       The Complications section records
                                                                       section records problems that           problems that occurred during the
                                                                       occurred during the procedure."         serviceEvent (e.g. during the
                                                                                                               procedure recorded in a Procedure
                                                                                                               Note).
                                                    4.18         A-S   "The History of Present Illness         …related to the service event (e.g.
                                                                       section describes the history related   related to the reason for the
                                                                       to the reason for the procedure."       procedure recorded in a Procedure
                                                                                                               Note).
                                                    4.19         A-T   "Hopsital Course Section"               "Hospital Course Section"


                                                    4.29         A-S   "The Medications Administered           "The Medications Administered
                                                                       section defines medications and         section defines medications and
                                                                       fluids administered during the          fluids administered during the
                                                                       procedure…"                             service event (e.g. during the
                                                                                                               procedure recorded in a Procedure
                                                                                                               Note)."
                                                    4.28         A-S   "Optional Entries"                      "Template for Entries Being
                                                                                                               optional"




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                 13                                                                   March 2003
                                                           V3 Ballot Submission/Resolution Form

                                                    4.28         A-S    "Required Entries"                   "Template for Entries Being
                                                                                                             Required"


                                                    4.2         Neg-Mj missing implementation of             inclusion of directions for
                                                                       documentation of NKDA/NKA.            documentation of NKDA/NKA

                                                    4.4         Neg-Mj missing implementation of             inclusion of directions for
                                                                       documentation of No known             documentation of No Known
                                                                       Problems                              Problems
                                                    4.48        Neg-Mj missing implementation of             inclusion of directions for
                                                                       documentation of No Procedures        documentation of No Procedures

                                                    4.50        Neg-Mj missing implementation of             inclusion of directions for
                                                                       documentation of No Results           documentation of No Results

                                                    4.40         A-C    UML Diagram



                                                    4.48         A-S    "Optional Entries"                   "Template for Entries Being
                                                                                                             optional"


                                                    4.48         A-S    "Required Entries"                   "Template for Entries Being
                                                                                                             Required"


                                                    4.50         A-S    "Optional Entries"                   "Template for Entries Being
                                                                                                             optional"


                                                    4.50         A-S    "Required Entries"                   "Template for Entries Being
                                                                                                             Required"


                                                    4.56         A-S    "Optional Entries"                   "Template for Entries Being
                                                                                                             optional"


                                                    4.56         A-S    "Required Entries"                   "Template for Entries Being
                                                                                                             Required"


                                                    5.4         Neg-Mi conformance statement #8, value set inclusion of a description of what
                                                                       for "value" not defined.            the value is to represent and the
                                                                                                           expected value set.



42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                  14                                                           March 2003
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                                                    5.25        Neg-Mj conformance statement #4, "SHALL value set not defined
                                                                       contain exactly one…code"

                                                    5           Neg-Mj no Comments template                     inclusion of a Comments
                                                                                                                Annotation template (like the HITSP
                                                                                                                C83 Comments module). I also
                                                                                                                strongly recommend a "MAY
                                                                                                                contain…Comment Annotation"
                                                                                                                conformance statement in EVERY
                                                                                                                section and entry template




                                                    5.6         Neg-Mi a. The <text> element points to the      element SHOULD include a
                                                                       text describing the problem being        reference element which SHOULD
                                                                       recorded; including any dates,           reference the narrative. The
                                                                       comments, et cetera. The                 reference/@value SHALL begin
                                                                       <reference> contains a URI in value      with a hash '#' mark.
                                                                       attribute. This URI points to the free
                                                                       text description of the problem in the
                                                                       document that is being described.
                                                                       b. The problem name SHOULD be
                                                                       recorded in the entry by recording a
                                                                       <reference> where the value
                                                                       attribute points to the narrative text
                                                                       containing the name of the problem.


                                                    5.11        Neg-Mi a. The 'text' elements SHOULD            element SHOULD include a
                                                                       contain a 'reference' element            reference element which SHOULD
                                                                       pointing to the narrative where the      reference the narrative. The
                                                                       severity is recorded, rather than        reference/@value SHALL begin
                                                                       duplicate text to avoid ambiguity.       with a hash '#' mark.
                                                    5.13        Neg-Mi i. A reference/@value can point to       element SHOULD include a
                                                                       its corresponding narrative (using       reference element which SHOULD
                                                                       the approach defined in CDA              reference the narrative. The
                                                                       Release 2, section 4.3.5.1 ).            reference/@value SHALL begin
                                                                                                                with a hash '#' mark.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                  15                                                                 March 2003
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                                                    5.2                Neg-Mi i. A reference/@value SHOULD         element SHOULD include a
                                                                              point to its corresponding narrative reference element which SHOULD
                                                                              (using the approach defined in CDA   reference the narrative. The
                                                                              Release 2, section 4.3.5.1 ).        reference/@value SHALL begin
                                                                                                                   with a hash '#' mark.
                                                    5.25               Neg-Mi i. A reference/@value SHOULD         element SHOULD include a
                                                                              point to its corresponding narrative reference element which SHOULD
                                                                              (using the approach defined in CDA reference the narrative. The
                                                                              Release 2, section 4.3.5.1 ).        reference/@value SHALL begin
                                                                                                                   with a hash '#' mark.
                                                    5.27                A-C a. element SHOULD include a
                                                                              reference element which SHOULD
                                                                              reference the narrative. The
                                                                              reference/@value SHALL begin with
                                                                              a hash '#' mark.
                                                    5.29               Neg-Mi i. A reference/@value SHOULD         element SHOULD include a
                                                                              point to its corresponding narrative reference element which SHOULD
                                                                              (using the approach defined in CDA reference the narrative. The
                                                                              Release 2, section 4.3.5.1 ).        reference/@value SHALL begin
                                                                                                                   with a hash '#' mark.
                                                    5.31                A-C a. element SHOULD include a
                                                                              reference element which SHOULD
                                                                              reference the narrative. The
                                                                              reference/@value SHALL begin with
                                                                              a hash '#' mark.
StructDocs     ??                       2           2.1                 A-Q The value of @value, if present,
                                                                              SHALL be precise to the day and
                                                                              SHOULD be precise to the minute.
                                                                              If precise to minute, SHOULD
                                                                              include time-zone offset
                                                                              (CONF:5257).
StructDocs     ??         Document      2           General             A-Q CONF-HP-23: Shall contain
                          Templates                 Header                    [1..1]effectiveTime
                                                    Constraints
                                                    -
StructDocs                              3           3.0                 A-S    Table 18 - Optional Sections
                                                    Document
                                                    Level
                                                    Template -
                                                    Table 18 -
                                                    CCD




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                         16                                                        March 2003
                                                                  V3 Ballot Submission/Resolution Form

StructDocs                              3           3.2                 A-S   An NPP is defined as any licensed medical           An NPP is defined as any licensed medical
                                                                              professional as recognized by the state in          professional as recognized by the state in
                                                    Consultatio
                                                                              which the professional practices, including,        which the professional practices, including,
                                                    n Note                    but not limited to, physician assistants, nurse     but not limited to, physician assistants, nurse
                                                                              practitioners, clinical nurse specialists, social   practitioners, clinical nurse specialists, social
                                                                              workers, physical therapists, and speech            workers, registered dietitians, physical
                                                                              therapists.                                         therapists, and speech therapists.



StructDocs                              3           3.8.1.2             A-S
                                                    ClinicalDo
                                                    cument/Co
                                                    de: Table
                                                    29
StructDocs                              4           Table 31            A-S   Allergies and Other Adverse
                                                                              Reactions

StructDocs                              4           4.11                A-S   This section records a narrative                    This section records a narrative
                                                    Discharge                 description of the expectations for                 description of the expectations for
                                                    Diet                      diet, including proposals, goals, and               diet and nutrition, including
                                                    Section                   order requests for monitoring,                      nutrition prescription,
                                                                              tracking, or improving the dietary                  proposals, goals, and order
                                                                              control of the patient, used in a                   requests for monitoring,
                                                                              discharge from a facility such as an                tracking, or improving the
                                                                              emergency department, hospital, or                  nutritional status dietary
                                                                              nursing home.                                       control of the patient, used in
                                                                                                                                  a discharge from a facility
                                                                                                                                  such as an emergency
                                                                                                                                  department, hospital, or
                                                                                                                                  nursing home.



StructDocs                              4           4.2                 A-Q   2. SHALL contain exactly one
                                                    Hospital                  [1..1] code/@code="48765-2"
                                                    Discharge                 Allergies, adverse reactions,
                                                    Diagnosis                 alerts (CodeSystem:
                                                    Section                   2.16.840.1.113883.6.1
                                                                              LOINC) (CONF:7980).




StructDocs                              4           4.49                A-T   This section records the patient's the              This section records the patient's the
                                                    Reason for                reason for the patient's visit (the                 reason for the patient's visit (as
                                                    Visit                     provider‟s description of the reason                documented by the provider‟s
                                                    Section                   for visit).                                         description of the reason for visit).
                                                    29299-5




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                            17                                                                                       March 2003
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StructDocs                              4           4.53                A-Q    Changes as reported by the patient or as documented by a member of the
                                                    Subjective                 patient's caregiver                   healthcare team
                                                    Section


StructDocs                              5           5.4                 A-S    The agent that is the cause of the
                                                    Allergy/Ale                allergy or adverse reaction is
                                                    rt                         represented as a manufactured
                                                    Observatio                 material participant playing entity in
                                                    n                          the allergy observation. . . . . In an
                                                                               allergy to a food or other substance
                                                                               the code@code SHALL be selected
                                                                               from the ValueSet
                                                                               2.16.840.1.113883.3.88.12.80.20
                                                                               Ingredient Name. (CONF:7421).

StructDocs                              5           5.4                Neg-Mi Table 39: Ingredient Name Value Set Unique ingredient identifiers
                                                    Allergy/Ale               Description: Unique identifiers for (UNIIs) for substances in drugs,
                                                    rt                        active drug ingredients.            biologics, foods, and devices.
                                                    Observatio
                                                    n
StructDocs                              5           5.4                Neg-Mi Table 39: Ingredient Name Value Set
                                                    Allergy/Ale
                                                    rt
                                                    Observatio
                                                    n




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                         18                                                            March 2003
                                                              V3 Ballot Submission/Resolution Form

StructDocs                              General     General        Neg-Mj




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                              19                    March 2003
                                                                 V3 Ballot Submission/Resolution Form

StructDocs                              General                       Neg-Mj




StructDocs                              General                       Neg-Mj



StructDocs                              General     Immunizati        Neg-Mj Believe the xml in the table showing Should be changed to this:
                                                    on                       a problem template id value is           cda:entryRelationship[@typeCode=‟
                                                                             incorrect. Believe that this in table 2- RSON‟]/ cda:act
                                                                             18
                                                                             cda:entryRelationship[@typeCode=‟ See also 2.2.2.13.2 Refusal Reason
                                                                             RSON‟]/ cda:act                          Constraints
                                                                             cda:templateId/@root=2.16.840.1.11 C154-[DE-13.10-1] The reason for
                                                                             383.10.20.1.27                           refusal SHALL be coded as
                                                                                                                      specified in HITSP/C80 Section
                                                                                                                      2.2.3.5.3 No Immunization Reason
                                                                                                                      And reviewing HITSP/C80 the No
                                                                                                                      Immunization Reason Value Set
                                                                                                                      does not look like a problem list.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                        20                                                                March 2003
                                                              V3 Ballot Submission/Resolution Form

StructDocs                              General     General        Neg-Mj




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                              21                    March 2003
                                                                 V3 Ballot Submission/Resolution Form

StructDocs                              General                       Neg-Mj




StructDocs                              General                       Neg-Mj



StructDocs                              General     Immunizati        Neg-Mj Believe the xml in the table showing Should be changed to this:
                                                    on                       a problem template id value is           cda:entryRelationship[@typeCode=‟
                                                                             incorrect. Believe that this in table 2- RSON‟]/ cda:act
                                                                             18
                                                                             cda:entryRelationship[@typeCode=‟ See also 2.2.2.13.2 Refusal Reason
                                                                             RSON‟]/ cda:act                          Constraints
                                                                             cda:templateId/@root=2.16.840.1.11 C154-[DE-13.10-1] The reason for
                                                                             383.10.20.1.27                           refusal SHALL be coded as
                                                                                                                      specified in HITSP/C80 Section
                                                                                                                      2.2.3.5.3 No Immunization Reason
                                                                                                                      And reviewing HITSP/C80 the No
                                                                                                                      Immunization Reason Value Set
                                                                                                                      does not look like a problem list.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                        22                                                                March 2003
                                                                  V3 Ballot Submission/Resolution Form

StructDocs                                          Table 11:          Neg-Mj
                                                    State Value
                                                    Set




StructDocs                                          5.26.5.a           Neg-Mj a. SHOULD be from LOINC            a. SHOULD be from LOINC
                                                                              (CodeSystem:                       (CodeSystem:
                                                                              2.16.840.1.113883.6.1) or          2.16.840.1.113883.6.1) or
                                                                              SNOMED CT (CodeSystem:             SNOMED CT (CodeSystem:
                                                                              2.16.840.1.113883.6.96), and MAY   2.16.840.1.113883.6.96), and MAY
                                                                              be selected from CPT-4             be selected from CPT-4
                                                                              (CodeSystem:                       (CodeSystem:
                                                                              2.16.840.1.113883.6.12)            2.16.840.1.113883.6.12)
                                                                              (CONF:7164).                       (CONF:7164).

                                                                                                                 Laboratry results SHOULD be from
                                                                                                                 LOINC (CodeSystem:
                                                                                                                 2.16.840.1.113883.6.1) or other
                                                                                                                 constrained terminology named by
                                                                                                                 the US Department of Health and
                                                                                                                 Human Services Office of National
                                                                                                                 Coordinator or other federal agency.
                                                                                                                 Local codes for laboratory results
                                                                                                                 SHOULD also be allowed.
StructDocs                                          5.26.5.a            A-S                                      Suggest add:

                                                                                                                 Regional codes for laboratory results
                                                                                                                 SHOULD also be allowed.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                       23                                                               March 2003
                                                                 V3 Ballot Submission/Resolution Form

StructDocs                                          5.27.5.a          Neg-Mj a. SHOULD be from LOINC                a. SHOULD be from LOINC
                                                                             (CodeSystem:                           (CodeSystem:
                                                                             2.16.840.1.113883.6.1) or              2.16.840.1.113883.6.1) or
                                                                             SNOMED CT (CodeSystem:                 SNOMED CT (CodeSystem:
                                                                             2.16.840.1.113883.6.96), and MAY       2.16.840.1.113883.6.96), and MAY
                                                                             be selected from CPT-4                 be selected from CPT-4
                                                                             (CodeSystem:                           (CodeSystem:
                                                                             2.16.840.1.113883.6.12)                2.16.840.1.113883.6.12)
                                                                             (CONF:7164).                           (CONF:7164).

                                                                                                                    Laboratry results SHOULD be from
                                                                                                                    LOINC (CodeSystem:
                                                                                                                    2.16.840.1.113883.6.1) or other
                                                                                                                    constrained terminology named by
                                                                                                                    the US Department of Health and
                                                                                                                    Human Services Office of National
                                                                                                                    Coordinator or other federal agency.
                                                                                                                    Local codes for laboratory results
                                                                                                                    SHOULD also be allowed.
StructDocs                                          5.27.5.a           A-S                                          Suggest add:

                                                                                                                    Regional codes for laboratory results
                                                                                                                    SHOULD also be allowed.
StructDocs                                          5.27.4 and         A-Q
                                                    5.27.5

StructDocs                                          4.23 and           A-Q
                                                    4.50



StructDocs     ??                                   1.7.4             Neg-Mi In the next figure, the constraint says ??
                                                                             only one Participant "like this" is to
                                                                             be present. Other participant
                                                                             elements are not precluded by this
                                                                             constraint.
StructDocs     ??                                   2.2               Neg-Mi SHALL not have mixed content            ??

StructDocs     ??                                   2.3               Neg-Mi SHALL not have mixed content           ??

StructDocs     ??                                   4.2               Neg-Mi Optional Entries/Required Entries      suggest definition and consistancy
                                                                                                                    on how section templateId
                                                                                                                    constrains whether the <entry> is
                                                                                                                    optional or required




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                         24                                                                March 2003
                                                                 V3 Ballot Submission/Resolution Form

StructDocs     ??                                   5.3               Neg-Mi 6. SHALL contain exactly one [1..1
                                                                             statusCode, which SHALL be
                                                                             selected from Value Set
                                                                             2.16.840.1.113883.11.20.919
                                                                             ProblemAct statusCode



StructDocs     ??                                   5.5               Neg-Mi same as 5.3

StructDocs     ??                                   5.25              Neg-Mj 10. SHOULD contain exactly one
                                                                             [1..1] entrRelationship (CONF:7580)
                                                                             such that it
StructDocs     ??                                   5.29              Neg-Mj This clinical statement represents the
                                                                             severity of the reaction to an agent.

StructDocs


StructDocs                                                            Neg-Mi




StructDocs                                          5.2, 5.11,        Neg-Mj
                                                    5.20




StructDocs                                          5.30.             Neg-Mj



StructDocs                                          5.31              Neg-Mj




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                        25                           March 2003
                                                                  V3 Ballot Submission/Resolution Form

StructDocs                                          4.2, 4.28,         Neg-Mj
                                                    4.48, 4.50,
                                                    4.56




StructDocs                                          5.14               Neg-Mj




StructDocs                                          All                Neg-Mj




StructDocs                              3           Document No         A-Q
                                                    type -
                                                    Discharge
                                                    Summary




StructDocs                              4           4.13          No    A-C


StructDocs                              4           4.18          No    A-C


StructDocs                              4           4.45          No    A-Q




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                  26                    March 2003
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StructDocs                              1.7.2             A-S




StructDocs                              1.7.6             A-S



StructDocs                              1.8.1             A-S


StructDocs                              1.8.3             A-S




StructDocs                              1.9               A-S


StructDocs                              2.1              Neg-Mi




StructDocs                              2.1               A-Q


StructDocs                              2.1.1            Neg-Mi


StructDocs                              3.1               A-S




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                    27                    March 2003
                                                    V3 Ballot Submission/Resolution Form

StructDocs                              passim            A-S




StructDocs                              5.4              Neg-Mi




StructDocs                              5.3               A-T


StructDocs                              4.13              A-Q


StructDocs                              4.19              A-T


StructDocs                              passim            A-Q


StructDocs                              4.24              A-S




StructDocs                              4.40              A-S


StructDocs                              passim            A-S




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                    28                    March 2003
                                                                V3 Ballot Submission/Resolution Form

StructDocs                              1.5                           A-S




StructDocs                              passim                        A-S




StructDocs                              5.31                          A-Q


StructDocs                              1            1.4             Neg-Mj The Consolidation Project team
                                        Introduction Approach               members completed the analysis by
                                                                            creating a fully compliant CCD
                                                                            document, then layering in the
                                                                            additional HITSP, IHE and
                                                                            Meaningful Use constraints. When a
                                                                            new constraint introduced an issue,
                                                                            conflict or ambiguity, the item was
                                                                            flagged for review with the full
                                                                            consolidation team. The full analysis
                                                                            covered the CDA Header, section-
                                                                            level and entry-level requirements
                                                                            sufficient for Meaningful Use.

                                                                             The consolidation of templates
                                                                             developed across these organizations
                                                                             and their publication in catalog form
                                                                             driven from model-based tools is a
                                                                             strong step toward satisfying the full
                                                                             range of requirements for clinical
                                                                             information use and reuse through
                                                                             templated CDA.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                       29                            March 2003
                                                                 V3 Ballot Submission/Resolution Form

StructDocs                Progress_Note 1            1.4              Neg-Mi All involved in the Consolidation
                          .xml          Introduction Approach                Project recognize the critical need
                                                                             for an intrinsic tie between the
                          MU_CCD.sam                                         human-readable conformance
                          ple.xml                                            requirements, the computable
                                                                             expression of those requirements, the
                                                                             production of validation test suites
                                                                             and application interfaces to
                                                                             facilitate adoption. To that end, the
                                                                             analysis performed by the volunteers
                                                                             and staff of the Consolidation
                                                                             Project was the prelude to data entry
                                                                             into a set of model-based tools.




StructDocs                Progress_Note             4.5               Neg-Mi Progress_note.xml indicates
                          .xml                      Assessmen                Assessment and Plan section
                                                    t and Plan               <templateId
                                                    Section -                root="2.16.840.1.113883.10.20.22.2
                                                    51487-2                  .9" />


                                                                              IG p. 108 states: [section: templateId
                                                                              2.16.840.1.113883.10.20.21.2.9(ope
                                                                              n)] while other references to the
                                                                              section template ID in the IG have
                                                                              the template ID found in the sample
                                                                              documents where Assessment and
                                                                              Plan are required
StructDocs                                          1.7.6              A-Q    MSK attribute: There is information
                                                    Figure 4                  on this item available but it has not
                                                    nullFlavor                been provided by the sender due to
                                                    example                   security, privacy, or other reasons.
                                                                              There may be an alternate
                                                    p.18                      mechanism for gaining access to this
                                                                              information.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                        30                            March 2003
                                                               V3 Ballot Submission/Resolution Form

StructDocs                                          1.4              A-T     The full analysis covered the CDA       The full analysis covered the CDA
                                                    Approach                 Header, section-level and entry-level   Header, section-level and entry-level
                                                                             requirements sufficient for             requirements sufficient for
                                                                             Meaningful Use The Project also         Meaningful Use. The Project also
                                                                             reviewed document and section-level     reviewed document and section-
                                                                             requirements for the full set of        level requirements for the full set of
                                                                             document types.                         document types.
StructDocs                              All                         Neg-Mi




StructDocs                              All                         Neg-Mi




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                       31                                                                    March 2003
                                                                 V3 Ballot Submission/Resolution Form

StructDocs                                          3.2.1.2            A-S     Use of these codes is not
                                                                               recommended, as this duplicates
                                                                               information potentially present in the
                                                                               header




StructDocs                                          All                A-S



StructDocs                                          Table 31:         Neg-Mi
                                                    Sections
                                                    and
                                                    Required/O
                                                    ptional
                                                    Document
                                                    Types

                                                    P.100

                                                    Allergies
                                                    and Other
                                                    Adverse
                                                    Reactions

                                                    Table 18:
                                                    Document
                                                    Types and
                                                    Required/O
                                                    ptional
                                                    Sections
                                                    p.40




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                         32                            March 2003
                                                                 V3 Ballot Submission/Resolution Form

StructDocs                Progress_Note             All               Neg-Mi
                          .xml




StructDocs                                          4.1                A-S     6. MAY contain exactly one [1..1]
                                                    Advance                    entry (CONF:7957)
                                                    Directives
                                                    Section
                                                    42348-3




StructDocs                CDAR2_IG_C 2.1                              Neg-Mi
                          ONSOL_R1_
                          D1_2011APR




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                        33                        March 2003
                                                               V3 Ballot Submission/Resolution Form

StructDocs                CDAR2_IG_C 2.1                             A-S
                          ONSOL_R1_
                          D1_2011APR


StructDocs                CDAR2_IG_C 2.1                             A-S
                          ONSOL_R1_
                          D1_2011APR


StructDocs                CDAR2_IG_C 2.1            6.a.             A-S     can either be a locally defined name MAY either be a locally defined
                          ONSOL_R1_                                          or …                                 name or …
                          D1_2011APR
StructDocs                CDAR2_IG_C 2.1.2          13.b.i.         Neg-Mj This assignedAuthor SHALL contain This assignedAuthor SHALL
                          ONSOL_R1_                                        exactly one [1..1] id             contain one or more [1..*] id
                          D1_2011APR




StructDocs                CDAR2_IG_C 2.1.2          13.b.           Neg-Mi -                                     SHALL include in id the physician‟s
                          ONSOL_R1_                                                                              National Provider Identifier (root
                          D1_2011APR                                                                             OID = 2.16.840.1.113883.4.6)

StructDocs                CDAR2_IG_C 2.1.2          13.b.           Neg-Mi -                                     SHOULD include in code a value
                          ONSOL_R1_                                                                              from coding system NUCC Health
                          D1_2011APR                                                                             Care Provider Taxonomy (OID =
                                                                                                                 2.16.840.1.113883.6.101)
StructDocs                CDAR2_IG_C 2.4                             A-S     When you know only the date ...
                          ONSOL_R1_                                          However, if you know the date ...
                          D1_2011APR
StructDocs                CDAR2_IG_C 2.4            1               Neg-Mj SHOULD contain exactly one [1..1]
                          ONSOL_R1_                                        serviceEvent/@classCode="PCPR"
                          D1_2011APR


StructDocs                CDAR2_IG_C 3              Table 18        Neg-Mi Required Sections | Optional
                          ONSOL_R1_                                        Sections
                          D1_2011APR
StructDocs                CDAR2_IG_C 3              Table 18        Neg-Mi
                          ONSOL_R1_
                          D1_2011APR




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                       34                                                             March 2003
                                                               V3 Ballot Submission/Resolution Form

StructDocs                CDAR2_IG_C 3              Table 18        Neg-Mi Procedures (6)
                          ONSOL_R1_                                        (6) Required only for inpatient
                          D1_2011APR                                       settings

StructDocs                CDAR2_IG_C    3           Table 18        Neg-Mi Diagnostic Imaging Report /
                          ONSOL_R1_                                        Findings (Radiology Comparison
                          D1_2011APR                                       Study - Observation)
StructDocs                CDAR2_IG_C    3           Table 18        Neg-Mi Diagnostic Imaging Report /
                          ONSOL_R1_                                        Radiology - impression
                          D1_2011APR
StructDocs                CDAR2_IG_C    3           Table 18        Neg-Mi Procedure Note /
                          ONSOL_R1_                                        Plan of Care
                          D1_2011APR
StructDocs                CDAR2_IG_C    3           Table 18        Neg-Mi Procedure Note /
                          ONSOL_R1_                                        Procedure Disposition
                          D1_2011APR
StructDocs                CDAR2_IG_C    3                           Neg-Mj <templateID>
                          ONSOL_R1_
                          D1_2011APR

StructDocs                CDAR2_IG_C 3.1                             A-S    C32                               HITSP C32
                          ONSOL_R1_
                          D1_2011APR
StructDocs                CDAR2_IG_C 3.2.1.2        Table 19         A-S
                          ONSOL_R1_
                          D1_2011APR
StructDocs                CDAR2_IG_C 3.2.2          7.a.            Neg-Mj A Consult Note can have either a
                          ONSOL_R1_                                        structuredBody or a nonXMLBody.
                          D1_2011APR




StructDocs                CDAR2_IG_C 3.3.1          1               Neg-Mj Conforms to US Realm Clinical
                          ONSOL_R1_                                        Document Header Template
                          D1_2011APR
StructDocs                CDAR2_IG_C 3.3.1.5                         A-T    inFullfillmentOf                  inFulfillmentOf
                          ONSOL_R1_
                          D1_2011APR




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                      35                                       March 2003
                                                               V3 Ballot Submission/Resolution Form

StructDocs                CDAR2_IG_C 3.3.1.6        8.a.iv          Neg-Mi This serviceEvent SHALL contain
                          ONSOL_R1_                                        exactly one [1..1]
                          D1_2011APR                                       effectiveTime/@value




StructDocs                CDAR2_IG_C 3.7            1               Neg-Mj Conforms to Consolidated US Realm
                          ONSOL_R1_                                        Header Template
                          D1_2011APR
StructDocs                CDAR2_IG_C 3.7.1.6        7.c.ii.1        Neg-Mi SHALL be selected from ValueSet
                          ONSOL_R1_                                        2.16.840.1.114222.4.11.1066
                          D1_2011APR                                       Healthcare Provider Taxonomy
                                                                           (NUCC - HIPAA)

StructDocs                CDAR2_IG_C 3.7                            Neg-Mi
                          ONSOL_R1_
                          D1_2011APR




StructDocs                CDAR2_IG_C 4                               A-S
                          ONSOL_R1_
                          D1_2011APR




StructDocs                CDAR2_IG_C 4.10           4               Neg-Mi SHALL NOT contain [0..0] title
                          ONSOL_R1_
                          D1_2011APR


StructDocs                CDAR2_IG_C 4.10           5               Neg-Mi SHALL NOT contain [0..0] text
                          ONSOL_R1_
                          D1_2011APR
StructDocs                CDAR2_IG_C 4.40                           Neg-Mi The following constraints apply to a The following constraints apply to a
                          ONSOL_R1_                                        Problem List section in which entries Problem List section in which
                          D1_2011APR                                       are required                          entries are not required
StructDocs                CDAR2_IG_C 4.40                           Neg-Mi SHOULD contain a case-insensitive
                          ONSOL_R1_                                        language-insensitive string
                          D1_2011APR                                       containing 'problems'.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                      36                                                              March 2003
                                                             V3 Ballot Submission/Resolution Form

StructDocs                CDAR2_IG_C General                        A-S     code/@code, which SHALL be         code, which SHALL be selected
                          ONSOL_R1_                                         selected from ValueSet             from ValueSet
                          D1_2011APR

StructDocs                CDAR2_IG_C General                        A-S     example:                           example:
                          ONSOL_R1_                                         SHALL contain exactly one [1..1]   SHALL contain exactly one [1..1]
                          D1_2011APR                                        code/@code="34133-9"               code = {"34133-9", LOINC,
                                                                            Summarization of Episode Note      "Summarization of Episode Note"}
                                                                            (CodeSystem:
                                                                            2.16.840.1.113883.6.1 LOINC)

StructDocs
StructDocs                              General     Change   Yes   Neg-Mj
                                                    Log




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                     37                                                          March 2003
                                                                   V3 Ballot Submission/Resolution Form

StructDocs                              General       Substantiv
                                                      e Changes




StructDocs                              1.7.2                           Neg-Mi
                                        Conformance
                                        Statements

StructDocs                              1.7.2                           Neg-Mj
                                        Conformance
                                        Statements

StructDocs                              1.7.2                            A-S
                                        Conformance
                                        Statements




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                                   38                    March 2003
                                                      V3 Ballot Submission/Resolution Form

StructDocs                              1.7.2               A-S
                                        Conformance
                                        Statements

StructDocs                              1.7.5              Neg-Mj
                                        Vocabulary
                                        Conformance




StructDocs                              1.7.5              Neg-Mi
                                        Vocabulary
                                        Conformance




StructDocs                              1.7.2              Neg-Mi
                                        Conformance
                                        Statements




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                      39                    March 2003
                                                      V3 Ballot Submission/Resolution Form

StructDocs                              1.7.2              Neg-Mi
                                        Conformance
                                        Statements

StructDocs                              1.7.2               A-S
                                        Conformance
                                        Statements




StructDocs                              1.7.2              Neg-Mi
                                        Conformance
                                        Statements

StructDocs                                                 Neg-Mj




StructDocs                                                 Neg-Mi




StructDocs                                                 Neg-Mj




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                      40                    March 2003
                                                          V3 Ballot Submission/Resolution Form




Comments

At least in laboratory reporting in the US, more than
one interpretation code can be provided with a
laboratory observation. Constraining this to a single
interpretation code per observation means the EHR
would possibly be dropping significant
interpretation codes provided by the originating
laboratory.
In the case of a laboratory result being included in a
CDA, it is extremely unlikely that the original result
from the lab will contain a hash '#' mark as
indicated, since a text attribute and narrative are
unlikely to be present in the original lab result. That
means the EHR is 'adding' this information and
creating a new observation. Where the EHR is
adding to the lab result (or result reported by another
diagnostic source) the EHR is the author not the
originating diagnostic source.

I believe you actually need two Result Observation
templates, one which faithfully reproduces the
observation from the originating diagnostic source
and does not include things "added" by the generator
of the document such as the has mark, where the
diagnostic source is the author of this observation. A
second template for observations that the EHR has
created and supplemented based on observations
from some other diagnostic source. The EHR would
be the author of this second observation. Both could
be present in a document and associated by a REFR
act relationship (not the best one from V3 but the
best one available in CDA).

I do know that Labs will have a real problem with




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                          41                    March 2003
                                                           V3 Ballot Submission/Resolution Form

This seems to imply that only "final" results are to
be included in this template. How are "corrected"
results which are a type of final result
communicated? Since the V3 state machine doesn't
actually have a "corrected" state, this was handled in
V3 Lab results as separate control act which has as
its subject the observation being corrected. The
control act code attribute carried the trigger event for
a corrected result. Fior CDa, that would be handled
via a subject act relationship (with the observation
as the target) to an "ACT" with a code attribute
carrying the corrected trigger event. This ties in with
"faithfully" reporoducing the result as reported by
the diagnostic source.




For example, section 1.3 says: All CDA templates
required for Final Rules for Meaningful Use are
included in this guide.
The syntax is confusing. I would not have
interpreted that it meant other participants are
allowed as well without the prior clause; I would
interpret it to mean that exactly one participant is
allowed, AND that participant must have exactly
one type code that is equal to LOC.




Which are normative, DSTU, informative or other?
E.g., is cda.xsl one of these statuses, and if so,
would changes to it require reballoting?
Clarify that codes such as en-US are also OK.




I'm glad that more than one patient ID are now
allowed - this was a weird IHE constraint.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                           42                    March 2003
                                                          V3 Ballot Submission/Resolution Form

Patients may not have a US address, if visiting from
overseas. Many foreign addresses do not contain
"state" for example. The same is true for guardians,
employers, etc. Adjust conformance statements
throughout to accommodate this.
I could be wrong, but I thought that minors could
have more than one guardian.

No reason to limit to one phone number.


These numeric state codes are not referenced
anywhere in the IG, and may confuse implementers
into using them rather than the normal state codes
(e.g., 12 vs. FL). I realize that the OIDs for the
values sets are different, but see no reason to include
this table at this point. If and when it is needed, its
use should be clear.
A very common scenario is that a clerk in the
medical records department creates a "push button"
CCD upon request of the patient. There is no single
identifiable human author in this case (the clerk may
have clicked the button, but did not author the
document). The author is an Organization in this
case. Need to explain how to represent this, and
change the cardinality of assignedPerson.

My understanding of this was that it conveyed legal
stewardship of the document. This wording seems
very watered down, implying little more than web
hosting.
Circular. Why does information recipient contain an
intended recipient which, in turn, contains an
information recipient?




My be a foreigner receiving treatment in the US.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                          43                    March 2003
                                                     V3 Ballot Submission/Resolution Form

As an XML attribute, there can only be one, but is
there a precedence we can define?


This is on the same level as "HV" for vacation
home, both with parent "H"




Immunization status is too vague. For each
document type that can contain immunizations,
specify the scope of time for immunizations
explicitly.




Contradiction between 3.3.1.10 section title and
section text. Is this meant to be the Physician of
Record Participant? (Section 2.19.1, Diagnostic
Imaging Report Implementation Guide)




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                     44                    March 2003
                                                         V3 Ballot Submission/Resolution Form

"PRF" typeCode is used instead of "ATND" which
is not consistent with the 3.3.1.11 section text and
section 2.19.1 of the Diagnostic Imaging Report
Implementation Guide.




Suggest URL links to pages on the ONC S&I
Framework wiki where each specific change is
discussed and rationale is provided. The changes
should be "what" and "why." If not possible to
provide documentation on every change all at once, I
suggest the top priority for change logging be given
to explaining any changes that affect Stage 1 MU
(changes to templates or constraints for Medications,
Allergies, Procedures, Results, Problems) since these
will have the widest impact on developers. In other
words, changes that deviate from CCD and HITSP
C83/C80 are more significant impacts than changes
that deviate from other templates (e.g., some
HealthStory or IHE)




I applaud the inclusion of this paragraph which
makes it clear that null flavors are allowed unless
specifically prohibited by a SHALL NOT statement.
This is an improvement over some other Igs that are
silent on the subject.
Lack of reference to HITSP C83 and C80
(mentioned only once). Because some value sets are
included herein, and because C80 is implicitly
required by reference from C83, there should be
clear statements whether value sets are different than
the C80 value sets that are already required in Stage
1 MU.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                         45                    March 2003
                                                          V3 Ballot Submission/Resolution Form

It says there are five required sections (Allergies,
Medications, etc.) for CCD, but the CCD
specification does not actually require these
sections. I have no objection to those sections as
they are required for MU, but technically I don't
think it is correct to say there are required in CCD
(or C32 for that matter). For example, in Table 31,
these sections are (correctly) listed as Optional

There is no section called "Plan" or is the Plan of
Care section being renamed? The table in 4 is not
consistent with section 4.35 which just says "Plan."
Which is the correct name? I suggest keeping the
name as Plan of Care for compatibility and
specificity (there could be "Plans" for other things
besides care)
Eliminate Constraint 6 "exactly one entry" because
there may be more than one AD document

Is it correct to say that a section can be within
another section, or was the intent to say that the
Procedures (not "the Procedure History section")
may be included in the History of Present Illness
section or may be included in a standalone
Procedures section?
CONF-144 says there must be a string containing
'problems' but the same XML contains no such
string. Should it say "problem" instead of
"problems"?
Fixed typo at beginning of 1st sentence. The last
sentence ("Local policy…") is confusing, because
there do not appear to be two things that could be
divided into two sections. What are the two things,
and IF they are divided into two sections, what
would the second section be?


The list of categories of results is not exhaustive, so
the text should say "such as" or "e.g.,"

The ballot comment spreadsheet formatting for the
Section Column should be changed to show 2 or
more decimals. Otherwise, it truncates trailing
zeroes and appears to refer to the wrong section. For
example I entered 4.50 and it displayed 4.5, so I had
to change the numeric format manually.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                          46                    March 2003
                                                          V3 Ballot Submission/Resolution Form

This is a "SHOULD" in CCD (CONF-388), and
making it a SHALL will force changes to MU-
compliant systems.
CONF-7576 appears to contradict CONF-7572 and
CONF-7574. 7572 says there SHALL be at least one
Med Entry containing a Med Activity. But CONF
7576 allows for there to be such a Med Activity OR
a Med Use None Known entry. Please clarify
whether CONF-7576 is the correct statement, in
which case CONF-7572 should be changed from
SHALL to MAY.
Leave it as it was before in both CCD and HITSP
C83. Why change the name to something more
fuzzy?
This is a "SHOULD" in CCD (CONF-381). Why
make it required?

Inconsistent spelling of this vocabulary. I suggest
changing all to SNOMED CT (space, no hyphen)
throughout because IHTSDO spells it that way

The way of expressing only one participant "like
this" is to be present is confusingly worded. It
appears to be a SHALL but it actually is a
conditional SHALL. So when used for actual
constraints, such as 7508 and 7513 in section 5.14,
it is hard to understand and the constraints appear to
be contradictory even though perhaps they are not. I
suggest expressing this type of constraint differently,
e.g., starting with the condition, e.g., IF medication
timing is represented with start and stop dates, there
shall be exactly one LOW effectiveTime and exactly
one HIGH effectiveTime.

Problem status value set is a superset of HITSP C80
(which only contained 3 values: now there are 8).
While this does not "break" existing systems, the
expansion means that some systems will send values
that other systems don't fully understand. Also, the
value set appears to have overlap (e.g., is "chronic"
can be "active" or "inactive" and similar overlap
exists for for "intermittent" and "recurrent")




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                          47                    March 2003
                                                         V3 Ballot Submission/Resolution Form

N-m: Constraints imposed by CDA should be
separated from those imposed elsewhere in the guide
and identified by the HMD row index (or via some
other mechanism) to enable the reader to understand
the source of the constraint.
CDA:xxxx in the above could be valued using the
HMD row index to specifically identify the source of
the constraint.
Related to lack of change log: it would help to have
in the IG, or an accompanying spreadsheet, a cross-
walk to the original implementation guides,
indicating whether the Consolidation Guide
constraints was taken "as is" from one of them, is
brand new, or has been modified based on an
existing IG.
SHALL on Problem Status (CONF-7320)
CDA Consolidation says that problem status is
required on allergies, whereas previously this entry
was optional in CCD, IHE and HITSP. This creates
unnecessary incompatibility with prior work, and as
all three had a different and CONSISTENT
constraint, this represents a change that goes beyond
the scope of work stated for the guide.

Code in the Allergy Problem Act is fixed to 48765-2
from LOINC. This represents a change from CCD,
IHE and HITSP specifications where
act/code/@nullFlavor = NA. These constraints
being consistent, we feel this change goes beyond
the scope of the guide. Furthermore, they introduce
needless incompatibility with prior work.

The condition act in the CDA Consolidation guide is
constrained for use with problems only, not
problems or allergies or other clinical statements
(e.g., an out of normal range lab result) as supported
in CCD, IHE and HITSP. This change results in
needless incompatibility with prior work.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                         48                    March 2003
                                                          V3 Ballot Submission/Resolution Form

Medication Use None Known
N-M: There are several distinct cases where drug
treatment information may not be present. IHE uses
the following different values, of which only the first
is supported in the CDA Consolidation guide for this
template. This template should allow for
“unknown”, but also for “known none”.
Medication 182904002 Drug Treatment Unknown
To indicate lack of knowledge about drug therapy
Medication 182849000 No Drug Therapy Prescribed
To indicate the absense of any prescribed
medications
Medication 408350003 Patient Not On Self-
Medications To indicate no treatment


There might not have a telephone for a patient.


There are several Section templates, e.g.
Medications Section, that have "Optional Entries"
and "Required Entries" templates. I recommend a
decent explanation of this paradigm…probably
within section 1.7 Conformance.

I could be mistaken, but I don't think that the
example included in Figure 3 actually represents the
situation of "only one LIKE this allowed".
this ballot fails to help the non-CDA-expert to know
what an element is intended to represent in
business/clinical terms. For example, what is the
"effectiveTime" in 2.1 supposed to represent? The
time the document was written, or signed, or the
clinical time to which the document is referring, etc.
Similar for "code", "setId", versionNumber, and so
on.
while the intro to this section says "the author may
be a device, a person, or an organization", there is no
documentation of how a device or an organization
should be done.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                          49                    March 2003
                                                           V3 Ballot Submission/Resolution Form

Noting the scenario of system generated documents
("Local policies MAY choose to delegate the
function of legal authentication to a device or system
that generates the clinical document"), many large
organizations (e.g. VA, DoD) will not be able to
provide a legal authenticating PERSON, as stated by
"In these cases, the legal authenticator is a person
accepting responsigbility for the document, not the
generating device or system). This element is a
SHOULD, so I guess it could be omitted in these
cases, or a representedOrganization could be
inserted, but this option is not provided.




several of the document level templates do have
participant constraints, but should these not be
further constraints on the general header participant
element?
there is a (partial) serviceEvent section, but it is not
anchored by "documentationOf". Several of the
document level templates do have documentationOf,
but should these not be further constraints on the
general header?
indeed, the intro for this section may be overly
specific, to "progress notes".

what is a "width" element? I have not seen such an
thing in a sample. If it is not an element or attribute,
the word needs to be described or replaced.

can we insert the Provider Taxonomy Code value
set?




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                           50                    March 2003
                                                          V3 Ballot Submission/Resolution Form




I suggest inclusion of a description of the "narrative
block" (text element), along the lines of section 4.3.5
(and 1.2.3) of CDA R2.
the current title implies that the following statements
are for elements that are optional, rather than a
template where you can omit the entries altogether

the current title implies that the following statements
are for required elements, rather than for a template
where you cannot omit the entries altogether.

this definition fits the concept of "plan" but not
"assessment"

this seems a bit overly specific to the procedure
note.



this seems a bit overly specific to the procedure
note.




this seems a bit overly specific to the procedure
note.




the current title implies that the following statements
are for elements that are optional, rather than a
template where you can omit the entries altogether




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                          51                    March 2003
                                                          V3 Ballot Submission/Resolution Form

the current title implies that the following statements
are for required elements, rather than for a template
where you cannot omit the entries altogether.

needed for MU, I believe.


needed for MU, I believe.


needed for MU, I believe.


needed for MU, I believe.


very helpful for following trail from section through
all the potential entries. Need to include for all
sections and possibly entries (at least those with
"children")
the current title implies that the following statements
are for elements that are optional, rather than a
template where you can omit the entries altogether

the current title implies that the following statements
are for required elements, rather than for a template
where you cannot omit the entries altogether.

the current title implies that the following statements
are for elements that are optional, rather than a
template where you can omit the entries altogether

the current title implies that the following statements
are for required elements, rather than for a template
where you cannot omit the entries altogether.

the current title implies that the following statements
are for elements that are optional, rather than a
template where you can omit the entries altogether

the current title implies that the following statements
are for required elements, rather than for a template
where you cannot omit the entries altogether.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                          52                    March 2003
                                                      V3 Ballot Submission/Resolution Form

required code, but no value set defined, nor is the
code described in any way.

Much experience has shown that implementers
commonly create (make up) different ways to
include "comments" fields in entry modules. Some
have used the occasionally required IHE <text> tag
associated with some of these entries to add such
information, some have used the generic "comments
module" (2.16.840.1.113883.3.88.11.83.11) to do so
(I assume this is the correct method), while others
have put them into originalText (even though the
text was not "originalText", but additional
comments).
As redundant as it may sound, I recommend a
conformance statement be inserted into each
section/entry to make it clear...in place... how to
provide comments.
Mostly I just recommend consistency in wording
across the several corresponding <text> elements
across the entry level templates.




Mostly I just recommend consistency in wording
across the several corresponding <text> elements
across the entry level templates.


Mostly I just recommend consistency in wording
across the several corresponding <text> elements
across the entry level templates.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                      53                    March 2003
                                                        V3 Ballot Submission/Resolution Form

Mostly I just recommend consistency in wording
across the several corresponding <text> elements
across the entry level templates.


Mostly I just recommend consistency in wording
across the several corresponding <text> elements
across the entry level templates.


I recommend consistency in wording across the
several corresponding <text> elements across the
entry level templates.


Mostly I just recommend consistency in wording
across the several corresponding <text> elements
across the entry level templates.


I recommend consistency in wording across the
several corresponding <text> elements across the
entry level templates.


How is time zone offset to be represented? Can you
include an example?




Does this include the date as well? If not, it should
be included.


CCD should also include Diet/Nutrition (with
similar content and structure as Discharge Diet
section) as an optional section in CCD. Diet and
Nutrition prescriptions/goals may be a critical
component of a patient's care. The American
Dietetic Association would like to see Diet and
Nutrition information required for CCD and at least
listed as optional for many of the other templates.
How should we pursue making this change given
that this is an implementation guide and such
changes are likely out of scope?




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                        54                    March 2003
                                                           V3 Ballot Submission/Resolution Form

Add registered dietitian to list of providers




Add LOINC 34801-1 Evaluation and management
note – Nutrition + Dietetics



This template should be required in the CCD as it is
often critical information to share among providers.

The American Dietetic Association has established
standardized language for the nutrition care process.
Coded terms for nutrition intervention and nutrition
monitoring and evaluation should optionally be
included in this section Reference: International
Dietetics and Nutrition Terminology (IDNT)
Reference Manual: Standardized Language for the
Nutrition Care Process. 3rd Ed. Chicago, IL:
American Dietetic Association; 2011. IDNT defines
"nutrition prescription" as "the patient/client's
individualized recommended dietary intake of
energy and/or selected foods or nutrients based on
current reference standards or dietary guidelines and
the patient/client's health condition and nutrition
diagnosis."
Shouldn't this reference template ID
2.16.840.1.113883.10.20.22.2.24?




Wording is confusing--is it the patient's stated
reason for the visit or the provider's interpretation of
the patient's reason for the visit?




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                           55                    March 2003
                                                           V3 Ballot Submission/Resolution Form

This can be ambiguous. Can this information be
provided by a PHR as documented by the patient, or
is the presumption that this is documented by a
member of the healthcare team?

It may be misleading to reference naturally ocurring
substances as manufactured materials without
indicating that this class may also include biologics.




The Substance Registration System/UNII scope
includes foods, drugs, biologics, devices and
cosmetics. Change the description to correspond
with this scope so as it is not limited solely to active
drug ingredients.
Add at least one example of a food allergen to table
39: Ingredient Name Value Set; e.g., peanut (UNII:
QE1QX6B99R)




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                           56                    March 2003
                                                          V3 Ballot Submission/Resolution Form

Based upon work thru IHE, we agree with and cite
their comments:

Lack of Change Log, and as a result, sufficient time
to review the material.
HL7 Publishing procedures require a change log to
be provided for materials that update preexisting
work. The information provided with the CDA
Consolidation ballot indicated that the entire content
of previous DSTUs had changed. The log was
insufficient to enable the reader to identify artifacts
that had change. Such information was only made
publically available to balloters about 10 days before
ballot close, which was insufficient time to properly
review the content.
The changes in this document represent
approximately 150 templates and 1000
conformances statements that needed to be manually
compared against more than 150 templates and 1800
conformance statements in other guides. About 10
of the templates in original use were retained
without change, representing substantive change in
more than 90% of the previously balloted content,
without adequate aids to the reader to understand the
ramifications for existing implementations.
Due to the complexity of the analysis, most
implementers, would I suspect, simply reimplement
using the new guide rather the reusing existing code.
Assuming a reader was able to compare templates at
1 minute per conformance statement needing review,




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                          57                    March 2003
                                                        V3 Ballot Submission/Resolution Form

based upon work thru IHE committee, we agree with
and cite their comments:

Volume of Substantive Change, and lack of
migration strategy between existing implementations
and the new guide.
The new guide substantively changes 90% of
existing work, and does not identify the changes
needed to enable existing software implementations
to be modified to support the new guide. Without a
migration strategy to move from old to new, and
given the volume of changes, implementers will
either embark upon costly (and reduntant) gap
analysis and upgrade of existing solutions, or simply
start over again. Neither is desirable given current
pressures upon the healthcare industry to deliver
software that will support “Meaningful Use Stage
2”. While CCD was but one part of meaningful use,
it was a fairly major one, requiring a great deal of
investment in testing and tools.
If the new guide had only strengthened existing
constraints, or at least provided a set of templates
that represented the strengthened constraints, the
situation would have been better. Even with a costly
gap analysis, existing software could have been
reused by adding a new template identifier to
existing implementations, and adding new features
where constraints had been strengthened. is unclear
Based upon comments in rows 1 and 2, it
whether or not these changes introduce an
unnecessary and costly backwards imcompatibility.

Immunization section was not consolidated.
Therefore this ballot is incomplete in terms of all
consolidation issues




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                        58                    March 2003
                                                          V3 Ballot Submission/Resolution Form

Based upon work thru IHE, we agree with and cite
their comments:

Lack of Change Log, and as a result, sufficient time
to review the material.
HL7 Publishing procedures require a change log to
be provided for materials that update preexisting
work. The information provided with the CDA
Consolidation ballot indicated that the entire content
of previous DSTUs had changed. The log was
insufficient to enable the reader to identify artifacts
that had change. Such information was only made
publically available to balloters about 10 days before
ballot close, which was insufficient time to properly
review the content.
The changes in this document represent
approximately 150 templates and 1000
conformances statements that needed to be manually
compared against more than 150 templates and 1800
conformance statements in other guides. About 10
of the templates in original use were retained
without change, representing substantive change in
more than 90% of the previously balloted content,
without adequate aids to the reader to understand the
ramifications for existing implementations.
Due to the complexity of the analysis, most
implementers, would I suspect, simply reimplement
using the new guide rather the reusing existing code.
Assuming a reader was able to compare templates at
1 minute per conformance statement needing review,




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                          59                    March 2003
                                                        V3 Ballot Submission/Resolution Form

based upon work thru IHE committee, we agree with
and cite their comments:

Volume of Substantive Change, and lack of
migration strategy between existing implementations
and the new guide.
The new guide substantively changes 90% of
existing work, and does not identify the changes
needed to enable existing software implementations
to be modified to support the new guide. Without a
migration strategy to move from old to new, and
given the volume of changes, implementers will
either embark upon costly (and reduntant) gap
analysis and upgrade of existing solutions, or simply
start over again. Neither is desirable given current
pressures upon the healthcare industry to deliver
software that will support “Meaningful Use Stage
2”. While CCD was but one part of meaningful use,
it was a fairly major one, requiring a great deal of
investment in testing and tools.
If the new guide had only strengthened existing
constraints, or at least provided a set of templates
that represented the strengthened constraints, the
situation would have been better. Even with a costly
gap analysis, existing software could have been
reused by adding a new template identifier to
existing implementations, and adding new features
where constraints had been strengthened. is unclear
Based upon comments in rows 1 and 2, it
whether or not these changes introduce an
unnecessary and costly backwards imcompatibility.

Immunization section was not consolidated.
Therefore this ballot is incomplete in terms of all
consolidation issues




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                        60                    March 2003
                                                       V3 Ballot Submission/Resolution Form

Since this is a US Realm specification, recommend
using the Two- letter State Abbreviations published
in Appendix B of the US Postal Service (USPS) Pub
28 Postal Addressing Standards.

http://pe.usps.com/text/pub28/welcome.htm

Since this is a US Realm specification, clarify that
vocabularies named by US federal agencies
responsible for healthcare (HHS, ONC, CMS) must
be implemented in support of national initiatives.
The Office of National Coordinator is curently
working on a constrained set of LOINC terms for
results that may be named for Meaningful Use Stage
2.

Additionally not all laboratory tests have LOINC
codes created so local codes should also be allowed.




Since this is a US Realm specification, suggesting
adding reference for regional codes. Some federally
funded regional initaitves are defining regional
codes.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                       61                    March 2003
                                                        V3 Ballot Submission/Resolution Form

Since this is a US Realm specification, clarify that
vocabularies named by US federal agencies
responsible for healthcare (HHS, ONC, CMS) must
be implemented in support of national initiatives.
The Office of National Coordinator is curently
working on a constrained set of LOINC terms for
results that may be named for Meaningful Use Stage
2.

Additionally not all laboratory tests have LOINC
codes created so local codes should also be allowed.




Since this is a US Realm specification, suggesting
adding reference for regional codes. Some federally
funded regional initaitves are defining regional
codes.
Should the cardinality match?
5.27.4 is 1..*
5.27.5 is 1..1
Laboratory results can be reported in 4.23 (Hospital
Discharge Studies Summary Section) and 4.50
(Results Section) Please clarify when to report as
part of a discharge summary vs. the results section.

this is not at all clear by the example that follows.




what is 'mixed content'?

what is 'mixed content'?

See 4.21 Hospital Dischrge Medicatins Section
(optional entries)
Other Required entires (e.g., 4.28 Medications
Section) identify conformance to the optional entries
template.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                        62                    March 2003
                                                         V3 Ballot Submission/Resolution Form

how does this status relate to the Allergy Status
observation? How can a Problem Act have a status
of Completed, Aborted, Active and Suspended,
when the Alert Status observation can be only
Active, Prior History and No Longer Active? For
that matter, what is the difference between an allert
that is Prior History and one that is No Longer
Active?
same comment as for allergies

forced severity observations on to the reaction rather
than the allergy. Existing IGs make no such
distinction. Has PC?
forced severity observations on to the reaction rather
than the allergy. Existing IGs make no such
distinction. Has PC?



Difficult to audit and trace template rules to the
source specifications used as input to this
consolidation. This is possible using the MDHT
consolidation model that was created by
programmatically merging templates from the source
models, but not in the TDB templates that were
created from a single hand-authored sample CDA
document instance.
There is value in retaining some abstract base
templates from the source specifications and not
creating redundant copies of conformance rules into
several templates that are closely related. This
duplication will make it difficult for implementers to
recognize common content in related templates, and
code implementations (e.g. in Java) will not benefit
from a common base class. One example is the CCD
Status Observation; its rules are now copied into 6
sub-templates (when consolidation is finished).

Vital Signs Organizer is based on Results Organizer
template and should require conformance to that
template and NOT duplicate all inherited
conformance rules.
Vital Sign Observation is based on Result template
and should require conformance to that template and
NOT duplicate all inherited conformance rules.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                         63                    March 2003
                                                      V3 Ballot Submission/Resolution Form

Sections that have two templates With and Without
required entries include incorrectly duplicated
conformance rules in the sub-template. The sub-
template (entries required) shall conform to the
section without entries, so it should not duplicate
conformance rules for code and text.

The sub-templates of IHE Medication for Normal,
Split, Tapered, Conditional, and Combination are
omitted from this specification. No resolution was
reached for their removal and no guidance is
included on how equivalent C32 documents may be
exchanged without use of these templates.

Lack of implemeter guidance on changes from
HITSP C32. Implemeters of the current C32 v2.5
Meaningful Use requirements cannot determine
what must be changed to support this new
specification without reviewing every rule of every
template and comparing (how?) with previous
specifications.
I know the document sections for Discharge
Summary were already approved. However, I
wonder if "Discharge Instructions" should be added?
Discharge instructions are required for Meaningful
Use. Section 3.4 indicates that Joint Commission
requires "Information provided to the patient and
family". Should it be included in Discharge
Summary, it's own document type, or part of the
"Unstructured" document type?
The Conformance statement example is for Advance
Directives, not Family History.

The Conformance statement example is for History
of Past Illness, not History of Present Illness.

Are the Implants (4.25) and Procedure Implants
(4.45) both required? How are they different?




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                      64                    March 2003
                                                     V3 Ballot Submission/Resolution Form

A distinction is drawn between 'open' and
'closed' templates, but no guidance is given on
how to indicate or determine whether a
template (or instance) assumes one of those
values. An example is given at 1.7.4 of how this
might be communicated, but the pattern is not
explicitly connected to the named modes.
Subsequent explicit use of "may" (e.g., in 4.18)
suggests a different approach.
Now I see that 'open' is appended to the OID:
let's state that in this definition. The example
alone is a bit subtle for certain readers.
Using a cardinality notation to indicate that an
element is not nullalble is novel. I think I'd
prefer not to see it that way but can't say why.

An Xpath example would make this easier to
read.

Articulate the convention for non-consolidated
entries; don't just show it.
E.g., 'in a shaded box,' or 'in a shaded box with
a note,' or 'with a note and with the
conformance id preceding rather than following
the statement'
If all xmls docs are samples, name them
congruently with 'sample' in the name

A consistent convention should be adopted with
regard to inherited constraints. This entry
repeats CDA constraint that id & code are
required but does not repeat CDA constraints
for classcode and moodcode. Further, it does
not indicate the lineage of inherited constraints.


Why does template id specify the root but not
the extension (which is noted at the top)?

Race code is listed twice. Update the CDA
spec to reflect the correct cardinality. Having
two just confuses the implementer.
Explain the "/C32" in the title. Even those who
know what it is may not understand the specific
assumptions regarding the relationship
between CCD and C32.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                     65                    March 2003
                                                        V3 Ballot Submission/Resolution Form

Header constraints illustrate the xpath,
helpfully. Class constraints should do so as
well.
E.g., allergy/alert observation: I assume this is
the observation class in the clinical statement,
but it's not specified.
It's more of a problem for 5.28 service delivery
location. There's no location in the clinical
statement--unless it's "playing entity." But it still
needs an act to connect it to the entry.

Allergy/alert observation is, on examination,
specifically a medication-related event
(according to CONF 7403). That should either
be relaxed to include food and environmental
allergies or renamed to make the scope
obvious.
Link to allergy/alert observation is broken


Why is family history section limited to one
entry?

"Hospital" misspelled


Having the LOINC code in the section header
may be helpful to some, but rationale not clear

Immunization history may need a more flexible
medication act, as it may not be possible to
record details (e.g., time) of medication, as in
5.14 medication activity CONF:7508

Problem list: diagram bears no clear
relationship to the text; could use exposition.

Need a general statement on when it's
appropriate to organize by section, subsection,
entry, or organizer. Different approaches are
mildly confusing.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                        66                    March 2003
                                                         V3 Ballot Submission/Resolution Form

Appendix B answers many questions I had
while reading; this introductory section should
explain in more detail what that appendix does.
In addition, it's still not clear whether the new
OIDs are meant to replace, supersede, or
coexist with the existing OID, and what the
original stewards' positions are. Please clarify.

At several points, an entry states that the
structured data 'should reference the narrative':
this assumes that the narrative is orginal and
the entry is an encoding of that narrative. But if
the information is extracted from a structured
repository and the narrative is constructed from
that information, the reference should point the
other way. The direction should allow for either
case.
We require PQ; do we not need to require the
units and stipulate the unit system?

These Approach section implies that a model-driven
approach was taken in the creation of this
implementation guide. However it's unclear what
model driven approch was used to create these ballot
materials.

 - What is the Methodology? The consolidated guide
should document the process for instantiating new
documents and how to test those documents against
a valid model.

 - The ballot materials include the Word document
IG and a set of sample documents, but there are no
model-driven, re-usable artifacts that allow
implementers to create documents that conform to
selected templates to support the statement that
model-driven tools were used. This IG does not
appear to be different from any of the other CDA IG
that have been produced in the past.
 - While it was noted that "Post-ballot, the Tdb will
be the source for generation of platform-independent
validation rules as Schematron", if this consolidated
specification is to be considered at all to be "model-
driven", the schematron should be part of the IG.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                         67                    March 2003
                                                        V3 Ballot Submission/Resolution Form

Many if not all the XML samples appear to have
been hand crafted using cut & paste given
inconsistencies found between sections in (at least)
two sample documents: Progress Note and MU
CCD. If one of the goals for this project was to
generate properly structured and cross referenced
implementation guides using a model driven
approach (i.e., MDHT), this goal was not met.

There are also inconsistencies in the documentation
of document types and required/optional sections
(table 18) in the IG and Table 31: Sections and
Required/Optional Document Types.

- Allergy section not identical despite comment in
Progress note stating "Allergies Section - Optional -
Copy from CCD sample". CCD example uses Alerts
section template ID:
2.16.840.1.113883.10.20.22.2.6 whereas Progress
Note example uses Allergies section template ID:
2.16.840.1.113883.10.20.22.2.6.1

Page 108 Assessment and Plan section templateID is
inconsistent with the OID in other chapters of the IG
(p. 101, 197).




Doesn't the use of the MSK nullFlavor have the
potential to disclose sensitive data?




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                        68                    March 2003
                                                           V3 Ballot Submission/Resolution Form

Missing the period between sentences.




If this intent of this guide is to "provide a single
source for implementing the following CDA
documents", these ballot materials have not
simplifed the process for implementers.
Inconsistencies found between templateIDs within
various sections of the IG and in the sample
documents is symptomatic of the need to use better
tools to ensure the guides and examples do not
introduce new ambiguities and errors in
implementation.

In addition, it was extremely difficult to review this
ballot unless one had participated in most of the
work group discussions since the process for
"creating a fully compliant CCD document, then
layering in the additional HITSP, IHE and
Meaningful Use constraints" was not documented in
the IG.
There is a problem with the narrative block if it is to
be created from structured content. A best-practices
mechanism is needed to ensure that a standard
approach describes the rules for creating the
narrative block from structured content when the
information included in the CDA is structured data
extracted from some system. Organizations are
currently forced to come up with their own rules
which results in very inconsistent rendering of CDA
documents.

This implementation guide should provide guidance
on how the narrative block is created from structured
content, if the narrative block is to be created at all.
The guide should provide a standard best-practices
mechanism for rendering structured content or the
guide should instruct that structured content is only
to be used as structured content and that narrative
content that originates as narrative content can only
be used as narrative content.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                           69                    March 2003
                                                        V3 Ballot Submission/Resolution Form

The Specialized by Specialty area in Table 19
should reiterate the recommendation in the previous
paragraph (noted in Existing Wording column) as a
reminder to implementers, as these codes may
otherwise be used and conflict with the author or
performer of the service act or the practice setting
noted by the LOINC document type code.

It is difficult to validate the harmonization of the
standards without a comparision tool. Also need
reference to decisions when harmonization resulted
in one standard over another.
Table 31 indicates that Allergies and Other Adverse
Reactions section template is Optional in CCD
whereas Table 18 indicates this is a required section
(Table 18 on page 40).

In fact, all section templates defined for the CCD
document type are noted to be optional in Table 31
whereas Table 18 indicates that Allergies,
Medications, Problem List, Results and Procedures
(for inpatient) are required sections.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                        70                    March 2003
                                                           V3 Ballot Submission/Resolution Form

There is no requirement in base CDA that the
content rendered in the narrative block match entries
that can be in that section resulting in the possibility
that the CDA document may contain structured data
that is not rendered (displayed) in that section. This
has the potential to be misleading to the clinician
reviewing the rendered document. In addition,
existing validation tools to detect differences
between the content of the narrative block and
structured data entries. Ithe clinician which seems
to be a conflicting requirement.

For example, in the Progress Note sample document,
the Assessment and Plan section contains three
observations in the narrative block, yet only one
structured content entry is included in the sample
document. The display name for the structured entry
does not match what was rendered in the narrative
block. These are issues that the consolidation
project should address.




While marked as “out of scope” for this version of
the CDA Consolidation IG, the guide includes the
conformance statement “6. MAY contain exactly one
[1..1] entry (CONF:7957)”, which allows for only
one external reference to an advance directive
document for the Advance Directive Section .

Per the CCD, a patient may have more than one
document: A healthcare proxy, living will, power of
attorney and DNR could all exist, each as a separate
document. The CCD, HITSP Template
2.16.840.1.113883.3.88.11.83.116, and IHE
Advance Directive Observation
1.3.6.1.4.1.19376.1.5.3.1.4.13.7 permit reference to
one advance directive document for each Advance
Directive Entry/Observation .
Suggest breaking out US Realm header constraints
from "best practice universal realm" header
constraints, to allow specification of UV constraints
for non-US realm IGs




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                           71                    March 2003
                                                         V3 Ballot Submission/Resolution Form

componentOf/encompassingEncounter is used in
most IGs. It would be useful to have a header
template for this ACT that consolidates the
requirements in one place, and that can be invoked
as needed by each of the IGs.
inFulfillmentOf/order is used in several IGs. It
would be useful to have a header template for this
ACT that consolidates the requirements in one place,
and that can be invoked as needed by each of the
IGs.
use conformance language


Healthcare providers may need to be identified not
only by their local institutional ID (assigned by
scoping organization), but also by National Provider
ID. Role.id should allow both to be recorded.
Also applies to other participations
(legalAuthenticator, etc.)

as a US realm header, NPI is required
Also applies to other participations


note 3.6.1.4 5.a.iii.2.a is a similar requirement on a
different participation. Should apply to all header
participations

Avoid use of 2nd person direct address


PCPR is an appropriate code in on a small number
of uses, and should not be specified in the general
US realm header requirements. This may be
appropriate as a further header constraint in specific
document types.
I would rather see a specific requirement (in a
separate row) for each section, using conformance
language and explicit cardinality.
Identification of LOINC codes for the document
types in this table is inappropriate, as many
document types allow different codes. It is unclear
what is the conformance language for these codes.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                         72                    March 2003
                                                       V3 Ballot Submission/Resolution Form

Identification of conformance language in a footnote
is inappropriate. Please use explicit conformance
language in the main table rows for conditionality

This is not a required Section


This is a required Section


This is not a required Section


This is not a required Section


Why are new templateIDs assigned to every
document level template? I thought the approach
was to consolidate under existing templateIDs




Place invalid codes in a separate table for clarity.


Table 18 lists required sections for Consult Note.
Specifying it can have a nonXMLBody is
inconsistent.
It is true that Consult Notes (in general) may not
have a structured body, this IG does not have to be
the guiding authority for such. This document
section should specify only structured body Consult
Notes. Unstructured documents are described by
Section 3.9
DIR is a Universal Realm IG. Since conformance to
US Realm Header is a separate template ID, why
invoke it here?
title, and twice in text




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                       73                    March 2003
                                                          V3 Ballot Submission/Resolution Form

While this is consistent with the balloted DIR spec,
it is an unnecessary constraint, and conflicts with
generic requirement in Section 2.4:
3.a. The serviceEvent/effectiveTime element
SHOULD be present with effectiveTime/low
element and SHALL include effectiveTime/high
element if a width element is not present.
Procedure Note is a Universal Realm IG. Since
conformance to US Realm Header is a separate
template ID, why invoke it here?
Procedure Note is a Universal Realm IG, and it
specifies this as a MAY, not SHALL. Such
requirements should be part of the US Realm
Header, not the Procedure Note additional
requirements for the header
The following requirement has not been included in
this consolidation:
CONF-PN-42: Sections and subsections SHALL
have a title and the title SHALL NOT be empty.
Presumably this applies not only to specified
sections, but also to additional sections added by an
implementation
I would rather see a table representation of the
section requirements, similar to that used in IHE,
rather than the verbose text. Especially with
forthcoming IGs with many entries (e.g., the
Radiology and Cardiology report IGs), it is critical
for non-technical users to be able to effectively
review the content at a summary level, similar to the
tabular presentation at the document level.

While this is consistent with the balloted DIR spec,
it is bad practice, and may conflict with generic style
sheets. It conflicts with CONF-PN-42: Sections and
subsections SHALL have a title and the title SHALL
NOT be empty.
While this is consistent with the balloted DIR spec,
it is bad practice, and may conflict with generic style
sheets
Where is the delimiter for “the following” - should it
be the end of a numbered section?

This is a further sub-constraint on title, not a
separate constraint.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                          74                    March 2003
                                                        V3 Ballot Submission/Resolution Form

When selecting a code from a value set, it is not
selecting just @code, but also @codeSystem,
@codeSystemName, and @displayName. Need a
general description of this pattern.
When specifying a specific code value, it is not
specifying just @code, but also @codeSystem,
@codeSystemName, and @displayName. Need a
general description of this pattern, and a simplified
requirement statement - no need to repeat the OID in
every invocation - one Coding System OID Table in
the document is sufficient.

Lack of Change Log, and as a result, sufficient time
to review the material.
N-M: HL7 Publishing procedures require a change
log to be provided for materials that update
preexisting work. The information provided with
the CDA Consolidation ballot indicated that the
entire content of previous DSTUs had changed. The
log was insufficient to enable the reader to identify
artifacts that had change. Such information was
only made publically available to balloters about 10
days before ballot close, which was insufficient time
to properly review the content.
The changes in this document represent
approximately 150 templates and 1000 conformance
statements that needed to be manually compared
against more than 150 templates and 1800
conformance statements in other guides. About 10
of the templates in original use were retained
without change, representing substantive change in
more than 90% of the previously balloted content,
without adequate aids to the reader to understand the
ramifications for existing implementations.
Due to the complexity of the analysis, most
implementers, would I suspect, simply reimplement
using the new guide rather the reusing existing code.
Assuming a reader was able to compare templates at
2 minutes per conformance statement needing
review, that amounts about 90 hours of effort, or
more than two weeks of analysis. Even at 30
minutes per template, that‟s still about two weeks of
analysis.
I spent approximately 20 hours build a tool to enable




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                        75                    March 2003
                                                         V3 Ballot Submission/Resolution Form

Volume of Substantive Change, and lack of
migration strategy between existing implementations
and the new guide.
The new guide substantively changes 90% of
existing work, and does not identify the changes
needed to enable existing software implementations
to be modified to support the new guide. Without a
migration strategy to move from old to new, and
given the volume of changes, implementers will
either embark upon costly (and reduntant) gap
analysis and upgrade of existing solutions, or simply
start over again. Neither is desirable given current
pressures upon the healthcare industry to deliver
software that will support “Meaningful Use Stage
2”. While CCD was but one part of meaningful use,
it was a fairly major one, requiring a great deal of
investment in testing and tools.
If the new guide had only strengthened existing
constraints, or at least provided a set of templates
that represented the strengthened constraints, the
situation would have been better. Even with a costly
gap analysis, existing software could have been
reused by adding a new template identifier to
existing implementations, and adding new features
where constraints had been strengthened.
Instead, the new guide strengthens some existing
constraints, and weakens others, meaning that there
is no backwards compatibility with existing
N-m: The
solutions. rules in the “Conformance Statements”
section are not applied uniformly throughout the
guide.

N-M: The use of (open) and (closed) and the
meaning of these is not described in the guide.
Please include definitions for these terms in the
overview.
A-S: I have rarely seen “closed” templates be used,
and ever rarer yet, a mix of “open” and “closed”
templates in a single guide. I believe that each guide
should discuss its philosophy regarding whether the
templates it defines are open or closed, and provide
a general rule on how the templates it defines are
created.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                         76                    March 2003
                                                         V3 Ballot Submission/Resolution Form

A-S: The repetition of “open” and/or “closed” for
each template is distracting. Perhaps guides should
only note variations from the general rule when there
are exceptions.
N-M: While it is clear that a value set is defined
separately from its binding (STATIC or
DYNAMIC), I have never seen an implementation
guide EVER bind statically to a value set in one
place, and dynamically in another, nor would this be
considered good practice, as it would introduce
different interpretations of the value set in the same
guide. The static or dynamic bindings used with the
guide should be described in the value set, rather
than in each use of the value set. This will simplify
text for the reader, as one can remove unnecessary
repetition of “static” and “dynamic” in all
appearances where the value set is used within a
single guide.


1. SHALL contain exactly one [1..1] participant
(CONF:2777) such that it
    a. SHALL contain exactly one [1..1]
@typeCode="LOC" (CodeSystem:
      2.16.840.1.113883.5.90 HL7ParticipationType)
(CONF:2230).
Is less Preferable than THIS:
1. SHALL contain exactly one [1..1] participant
(CONF:2777) such that it
a. SHALL contain exactly one [1..1] @typeCode
whose value comes from the HL7ParticipationType
Code System (2.16.840.1.113883.5.90) (CDA:xxxx)
b. SHALL contain @typeCode="LOC" meaning
“Location” (CONF:2230).


N-m: Constraints imposed by CDA should be
separated from those imposed elsewhere in the guide
and identified by the HMD row index (or via some
other mechanism) to enable the reader to understand
the source of the constraint.
CDA:xxxx in the above could be valued using the
HMD row index to specifically identify the source of
the constraint.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                         77                    March 2003
                                                        V3 Ballot Submission/Resolution Form

N-m: Constraints should been rephrased so that it
reads in English first, with data used for machine
processing in following. See the example above.

A-S: Note that the second constraint takes the form
@typeCode=”CODE” meaning “Display Name”. It
need not repeat the value set constraint since that
was already fixed in the preceding constraint.
The general pattern for coded data becomes:
• Shall contain @code whose value comes from the
„CodeSystemName‟ Code System (codeSystem
OID)
• Shall contain @code whose value comes from the
„ValueSetName‟ Value Set (valueSet OID)
• Contains @code = „code‟ meaning „displayName‟
from the „CodeSystemName‟ code system
(codeSystem)


N-m: The text “exactly one [1..1]” can be omitted
on attribute constraints because shall contain @code
implies shall contain exactly one [1..1] @code
according to XML rules for attributes.
At the outset of this project, the Documentation
Workgroup outlined a set of requirements. This
guide failed to meet many of these requirements
which we feel are essential to support
implementation.
N-m: 6. The guide will use readily understandable
terms and methods, or when domain specific terms
or methods are used, will explain the domain
specific content to enable implementers who are not
familiar with the domain (e.g., HL7 V3 Modeling)
to understand what is being said
e.g.: open/closed not defined, static/dynamic
repeated unnecessarily,


N-M: 8. The new implementation guide (IG) must
collapse the numerous CDA IGs upon which C32
and other clinical content specifications are based,
to present a single "collapsed" view.
e.g., there is no way to see the “collapsed” view.
This is simply a brand new guide that does not relate
its constraints to those from CDA, CCD, IHE or
HITSP implementation specifications.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Ballot]                        78                    March 2003
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 Resolving a ballot:
 Please complete all green columns as described below - columns in blue are for the ballot submitters.
 You are required to send resolved ballots back to the ballot submitter, as denoted by the Submitter worksheet.

 Submitting comments on behalf of another person:
 You can cut and paste other peoples comments into your spreadsheet and manually update the column titled "On behalf of" or you
 can use a worksheet with the amalgamation macro in it (available from HL7 Inc. or HL7 Canada (hl7canada@cihi.ca)). The
 amalgamation worksheet contains the necessary instructions to automatically populate the 'submitter', 'organization' and
 'on behalf of' columns. This is very useful for organizational members or international affiliates who have one representative
 for ballot comments from a number of different people.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Instructions]                                                                                               August, 2002
                                            Ballot Submission/Resolution Instructions

  Column Headers
                                              Ballot Submitter (sections in lavender)

  Number                  This is an identifier used by HL7 Committees. Please do not alter.
  Ballot WG               Select the WG from the drop down list that will best be able to resolve the ballot comment.

                          In some situations, the ballot comment is general in nature and can best be resolved by a non-chapter
                          specific WG. This can include MnM (Modeling and Methodology) & INM (Infrastructure and
                          Management). Enter these WGs if you feel the ballot can best be resolved by these groups. In some
                          situations, chapter specific WGs such as OO (Observation and Orders) and FM (Financial Management)
                          will refer ballot comments to these WGs if they are unable to resolve the ballot comment. An explanation
                          of the 'codes' used to represent the Ballot WGs as well as the Ballots they are responsible for is included in
                          the worksheet titled 'CodeReference'
  Artifact                The type of Artifact this Change affects.
                          HD            Hierarchical Message Definition
                          AR            Application Roles
                          RM            Refined Message Information Model
                          IN            Interaction
                          TE            Trigger Event
                          MT            Message Type
                          DM            Domain Message Information Model
                          ST            Storyboard
                          ??            Other


  Section                 Section of the ballot, e.g., 3.1.2. Note: This column can be filtered by the committee, for example, to
                          consider all ballot line items reported against section 3.1.2.
  Ballot                  A collection of artifacts including messages, interactions, & storyboards that cover a specific interest area.
                          Examples in HL7 are Pharmacy, Medical Devices, Patient Administration, Lab Order/Resulting, Medical
                          Records, and Claims and Reimbursement.

                          Select from the drop down list the specific ballot that the comment pertains to. An explanation of the
                          'codes' used to represent the Ballots as well as the Ballot WGs that are are responsible for them is
                          included in the worksheet titled 'CodeReference'. Please refer to the list of available ballots on the HL7
                          site for more descriptive information on current, open ballots.
  Pubs                    If the submitter feels that the issue being raised directly relates to the formatting or publication of this
                          document rather than the content of the document, flag this field with a "Y" value, otherwise leave it blank
                          or "N".


42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Instructions]                                                                                    August, 2002
                                            Ballot Submission/Resolution Instructions

  Vote/Type               Negative Votes:

                          1. (Neg-Mj) Negative Vote with reason , Major. Use this in the situation where the content of the material is
                          non-functional, incomplete or requires correction before final publication. All Neg-Mj votes must be
                          resolved by committee.

                          2. (Neg-Mi) Negative Vote with reason, Minor Type. Use this when the comment needs to be resolved, but
                          is not as significant as a negative major.

                          Affirmative Votes:

                          3. (A-S) Affirmative Vote with Comment - Suggestion. Use this if the committee is to consider a
                          suggestion such as additional background information or justification for a particular solution.

                          4. (A-T) Affirmative Vote with Comment - Typo. If the material contains a typo such as misspelled words,
                          enter A-T.

                          5. (A-Q) Affirmative Vote with Question.

                          6. (A-C) Affirmative Vote with Comment.
  Existing Wording        Copy and Paste from ballot materials.
  Proposed Wording        Denote desired changes.

                          Reason for the Change. In the case of proposed wording, a note indicating where the changes are in the
  Comments
                          proposed wording plus a reason would be beneficial for the WG reviewing the ballot.
  In Person Resolution    Submitters can use this field to indicate that they would appreciate discussing particular comments in
  Required?               person during a WG Meeting. Co-Chairs can likewise mark this field to indicate comments they think
                          should be discussed in person. Please note that due to time constraints not all comments can be reviewed
                          at WGMs.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Instructions]                                                                                   August, 2002
                                            Ballot Submission/Resolution Instructions

                                          Committee Resolution (sections in turquoise)
  Comment Grouping        This is a free text field that WGs can use to track similar or identical ballot comments. For example, if a
                          committee receives 10 identical or similar ballot comments the WG can place a code (e.g. C1) in this
                          column beside each of the 10 ballot comments. The WG can then apply the sort filter to view all of the
                          similar ballot comments at the same time.
  Disposition             The instructions for selecting dispositions were too large for this section and have been moved to the
                          worksheet titled "Instructions Cont.."




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Instructions]                                                                                 August, 2002
                                              Ballot Submission/Resolution Instructions

  Withdraw                 Withdraw
  (Negative Ballots        This code is used when the submitter agrees to "Withdraw" the negative line item. The Process
  Only)                    Improvement Committee is working with HL7 Headquarters to clarify the documentation on 'Withdraw" in
                           the HL7 Governance and Operations Manual. To help balloters and co-chairs understand the use of
                           "Withdraw", the following example scenarios have been included as examples of when "Withdraw" might
                           be used: 1) the WG has agreed to make the requested change, 2) the WG has agreed to make the
                           requested change, but with modification; 3) the WG has found the requested change to be persuasive but
                           out-of scope for the particular ballot cycle and encourages the ballotter to submit the change for the next
                           release; 4) the WG has found the requested change to be non-persuasive and has convinced the
                           submitter. If the negative ballotter agrees to "Withdraw" a negative line item it must be recorded in the
                           ballot spreadsheet.

                           The intent of this field is to help manage negative line items, but the WG may elect to manage affirmative
                           suggestions and typos using this field if they so desire.

                           This field may be populated based on the ballotter's verbal statement in a WGM, in a teleconference or
                           in a private conversation with a WG co-chair. The intention will be documented in minutes as appropriate
                           and on this ballot spreadsheet. The entry must be dated if it occurs outside of a WGM or after the
                           conclusion of WGM.

                           The field will be left unpopulated if the ballotter elects to not withdraw or retract the negative line item.

                           Note that a ballotter often withdraws a line item before a change is actually applied. The WG is obliged
                           to do a cross check of the Disposition field with the Change Applied field to ensure that they have
                           finished dealing with the line item appropriately.

                           Retract
                           The ballotter has been convinced by the WG to retract their ballot item. This may be due to a
                           decision to make the change in a future version or a misunderstanding about the content.

                        NOTE: If the line item was previously referred, but withdrawn or retracted once the line item is dealt with
                        in the subsequent WG update the disposition as appropriate when the line item is resolved.
  Disposition Committee If the Disposition is "Refer", then select the WG that is ultimately responsible for resolving the ballot
                        comment. Otherwise, leave the column blank. If the Disposition is "Pending" for action by another WG,
                        select the appropriate WG.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Instructions]                                                                                    August, 2002
                                             Ballot Submission/Resolution Instructions

  Disposition Comment Enter a reason for the disposition as well as the context. Some examples from the CQ WG include:
                      20030910 CQ WGM: The request has been found Not Persuasive because....
                      20031117 CQ Telecon: The group agreed to the proposed wording.
                      20031117 CQ Telecon: Editor recommends that proposed wording be accepted.


  Responsible Person       Identifies a specific person in the WG (or disposition WG) that will ensure that any accepted changes are
                           applied to subsequent materials published by the WG (e.g. updating storyboards, updating DMIMs, etc.).

  For, Against, Abstain    In the event votes are taken to aid in your line item resolutions, there are three columns available for the
                           number of each type of vote possible, for the proposed resolution, against it or abstain from the vote.
  Change Applied           A Y/N indicator to be used by the WG chairs to indicate if the Responsible Person has indeed made the
                           proposed change and submitted updated materials to the committee.
                           A Y/N indicator to be used by the WG chairs to indicate if the line item is a substantive change.
  Substantive Change       NOTE: This is a placeholder in V3 pending definition of substantive change by the ArB.
                           This column is auto filled from the Submitter Worksheet. It is used to refer back to the submitter for a
                           given line item when all the ballot line items are combined into a single spreadsheet or database. For
                           Organization and Benefactor members, the designated contact must be one of your registered voters to
  Submitted By             conform with ANSI guidelines.
                           This column is auto filled from the Submitter Worksheet. Submitter's should enter the name of the
                           organization that they represent with respect to voting if different from the organization that they are
                           employed by. It is used to link the submitter's name with the organization they are voting on behalf of for a
  Organization             given line item when all the ballot line items are combined into a single spreadsheet or database.
                         This column is autofilled from the Submitter Worksheet. It is used to track the original submitter of the line
                         item. Many International Affiliates, Organizational, and Benefactor balloters pool comments from a variety
  On Behalf Of           of reviewers, which can be tracked using this column.
                         This column is autofilled from the Submitter Worksheet. It is used to track the email address of the original
                         submitter of the line item. Many International Affiliates, Organizational, and Benefactor balloters pool
  On Behalf Of Email     comments from a variety of reviewers, which can be tracked using this column.
  Submitter Tracking ID #Internal identifier (internal to the organization submitting the ballot). This should be a meaningful number
                         to the organization that allows them to track comments. This can be something as simple as the
                         reviewer‟s initials followed by a number for each comment, i.e. JD-1, or even more complex such as
                         „001XXhsJul03‟ where „001‟ is the unique item number, „XX‟ is the reviewer's initials, „hs‟ is the company


  Referred To              Use this column to indicate the WG you have referred this ballot comment to.



42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Instructions]                                                                                    August, 2002
                                           Ballot Submission/Resolution Instructions

  Received From           Use this column to indicate the WG from which you have received this ballot comment.
                          This is a free text field that WGs can use to add comments regarding the current status of referred or
  Notes                   received item.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Instructions]                                                                            August, 2002
                                             Ballot Submission/Resolution Instructions

                                                                                                         Back to ballot           Back to instructions
Ballot instructions continued...
For the column titled "Disposition" please select one of the following:

Applicable to All Ballot Comments (Affirmative and Negative)
1. Persuasive. The WG has accepted the ballot comment as submitted and will make the appropriate change in the next ballot cycle. At this point the
comment is considered withdrawn and the corresponding cell from the column titled „Withdrawn‟ should be marked appropriately. Section 14.08.01.03
of the HL7 Governance and Operations Manual (GOM) states that if a ballot comment is to be withdrawn that “…the Work Group effecting reconciliation
agrees without objection that the poistion expressed by the negative response is persuasive” and therefore WGs must take a vote to accept the
comment as persuasive.

2. Persuasive with Mod. The WG believes the ballot comment has merit, but has changed the proposed solution given by the voter. Example
scenarios include, but are not limited to;
-The WG has accepted the intent of the ballot comment, but has changed the proposed solution
-The WG has accepted part of the ballot comment, and will make a change to the standard; the other part is not persuasive
-The WG has accepted part of the ballot comment, and will make a change to the standard; the other part may be persuasive but is out of scope
The standard will be changed accordingly in the next ballot cycle. The nature of, or reason for, the modification is reflected in the Disposition Comments.
At this point the comment is considered withdrawn and the corresponding cell from the column titled „Withdrawn‟ should be marked appropriately.
Section 14.08.01.03 of the HL7 Governance and Operations Manual (GOM) states that if a ballot comment is to be withdrawn that “…the Work Group
effecting reconciliation agrees without objection that the poistion expressed by the negative response is persuasive” and therefore WGs must take a
vote to accept the comment as persuasive.

3. Not Persuasive. The WG does not believe the ballot comment has merit or is unclear. Section 14.08.01.02 of the HL7 GOM states that “Approval of
a motion to declare a negative response not persuasive shall require an affirmative vote of at least sixty percent (60%) of the combined affirmative and
negative votes cast by the Work Group during reconciliation.” A change will not be made to the standard or proposed standard. The WG must indicate a
specific reason why the ballot comment is rejected in the Disposition Comments. The ballot submitter has the option to appeal this decision following
HL7 procedures as defined in section 14.12 of the HL7 GOM.
Example scenarios include, but are not limited to;
- the submitter has provided a recommendation or comment that the WG does not feel is valid
- the submitter has not provided a recommendation/solution; the submitter is encouraged to submit a proposal for a future ballot
- the recommendation/solution provided by the submitter is not clear; the submitter is encouraged to submit a proposal for a future ballot

4. Not Persuasive with Mod. The comment was considered non-persuasive by the WG; however, the WG has agreed to make a modification to the
material based on this comment. For example, adding additional explanatory text. Additional changes suggested by the non-persuaive comment will
not be made to the standard or proposed standard. The WG must indicate a specific reason why the ballot comment is rejected in the Disposition
Comments. The ballot submitter has the option to appeal this decision following HL7 procedures as defined in section 14.12 of the HL7 GOM.

5. Not Related. The WG has determined that the ballot comment is not relevant to the domain at this point in the ballot cycle. Section 14.08.01.01 of
the HL7 GOM states that “Approval of a motion to declare a negative response not related shall require an affirmative vote of at least sixty percent
(60%) of the combined affirmative and negative votes cast by the Work Group during reconciliation.” Example scenarios include, but are not limited to;


42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Instructions Cont..]                                                                                 August, 2002
                                            Ballot Submission/Resolution Instructions
(60%) of the combined affirmative and negative votes cast by the Work Group during reconciliation.” Example scenarios include, but are not limited to;
- the submitter is commenting on a portion of the standard, or proposed standard, that is not part of the current ballot
- the submitter's comments may be persuasive but beyond what can be accomplished at this point in the ballot cycle without creating potential
controversy.
- the submitter is commenting on something that is not part of the domain

6. Referred and Tracked. This should be used in circumstances when a comment was submitted to your WG in error and should have been submitted
to another WG. If you use this disposition you should also select the name of the WG you referred the comment to under the Column "Referred To".

7. Pending Input from Submitter. This should be used when the WG has read the comment but didn't quite understand it or needs to get more input
from the submitter. By selecting "Pending Input from Submitter" the WG can track and sort their dispositions more accurately.

8. Pending Input from other WG. The WG has determined that they cannot give the comment a disposition without further input or a final decision
from another WG. This should be used for comments that do belong to your WG but require a decision from another WG, such as ArB or MnM.

Applicable only to Affirmative Ballot Comments
9. Considered for future use. The WG, or a representative of the WG (editor or task force), has reviewed the item and has determined that no change
will be made to the standard at this point in time. This is in keeping with ANSI requirements. The reviewer should comment on the result of the ballot
comment consideration. An Example comment is included here:
- the suggestion is persuasive, but outside the scope of the ballot cycle; the submitter is encouraged to submit a proposal to the WG using the agreed
upon procedures.

10. Considered-Question answered. The WG, or a representative of the WG (editor or task force), has reviewed the item and has answered the
question posed. In so doing, the WG has determined that no change will be made to the standard at this point in time. This is in keeping with ANSI
requirements.

11. Considered-No action required. Occasionally people will submit an affirmative comment that does not require an action. For example, some WG's
have received comments of praise for a job well done. This comment doesn't require any further action on the WG's part, other than to keep up the
good work.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Instructions Cont..]                                                                              August, 2002
                                                           Ballot Submission/Resolution Instructions




     int the

econciliation




 Comments.




           of

st indicate a




                42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Instructions Cont..]                         August, 2002
                                                          Ballot Submission/Resolution Instructions




en submitted


more input




t no change




 some WG's




               42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Instructions Cont..]                         August, 2002
                                                               V3 Ballot Submission/Resolution Form


  Note on entering large bodies of text:
  ------------------------------------------------------------------
  When entering a large body of text in an Excel spreadsheet cell:

  1) The cell is pre-set to word wrap

  2) You can expand the column if you would like to see more of the available data

  3) There is a limit to the amount of text you can enter into a "comment" text column so keep things brief.
     -For verbose text, we recommend a separate word document; reference the file name here and include it (zipped) with your ballot.

  4) To include a paragraph space in your lengthly text, use Alt + Enter on your keyboard.

  5) To create "bullets", simply use a dash "-" space for each item you want to
  "bullet" and use two paragraph marks between them (Alt + Enter as described
  above).
  ------------------------------------------------------------------




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Format Guidelines]                          90                                                March 2003
                                                               V3 Ballot Submission/Resolution Form




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Format Guidelines]                    91                    March 2003
                                                                 V3 Ballot Submission/Resolution Form


 Note: This section is a placeholder for Q&A/Helpful Hints for ballot resolution. (These notes are from Cleveland Co-Chair meeting; needs to be edited, or replaced by use cases)

 Marked ballots
 Issue For second and subsequent membership ballots HL7 ballots only the substantive changes that were added since the last ballot, with the instructions that ballots returned on unmarked ite
 “not related”. How do you handle obvious errors that were not marked, for example, the address for an external reference (e.g. DICOM) is incorrect?
 Response You can correct the obvious typographical errors as long as it is not a substantive change, even if it is unmarked. We recommend conservation interpretation of “obvious error” as y
 make a change that will questioned, or perceived to show favoritism. If you are unclear if the item is an “obvious error” consult the TSC Chair or ARB.
 Comment With the progression of ballots from Committee - > Membership the closer you get to final member ballot, the more conservative you should be in adding content. In the early stag
 ballot, it may be acceptable to adding new content (if endorsed by the committee) as wider audiences will review/critique in membership ballot. The Bylaws require two levels of ballot for n
 to Section 14.01). Exceptions must approved by the TSC Char.

 Non-persuasive
 Issue Use with discretion· Attempt to contact the voter before you declare their vote non-persuasive· Fixing a problem (e.g. typo) in effect makes the negative vote non-persuasive.· In all case
 be informed of the TC‟s action.
 Response The preferred outcome is for the voter to withdraw a negative ballot; It is within a chair‟s prerogative to declare an item non-persuasive. However, it does not make sense to declar
 without attempting to contact the voter to discuss why you are declaring non-persuasive. If you correct a typo, the item is no longer (in effect) non-persuasive once you have adopted their re
 change, however the voter should then willingly withdraw their negative as you have made their suggestion correction.. In all cases, you must inform the voter.
 Comment


 Non-related
 Issue Use with discretion· Used, for example, if the ballot item is out of scope, e.g. on a marked ballot the voter has submitted a comment on an area not subject to vote.· Out of scope items
 Response
 Comment


 Non-standard ballot responses are received
 Issue The ballot spreadsheet allows invalid combination, such as negative typo.
 Response Revise the ballot spreadsheets to support only the ANSI defined votes, plus “minor” and “major” negative as requested by the committees for use as a management tool. Question w
 Suggestion will be retained
 Comment Separate Affirmative/Abstain and Negative ballots will be created. Affirmative ballots will support: naffirmativenaffirmative with commentnaffirmative with comment
 comment – suggestionnabstainNegative ballots will support:nnegative with reason – majornnegative with reason – minorNote: “major” “minor” need definition

 Substantive changes must be noted in ballot reconciliation
 Issue Who determines whether a ballot goes forward?
 Response Substantive changes in a member ballot will result in a subsequent ballot. These should be identified on the ballot reconciliation form. (Refer to Bylaws 15.07.03). The TSC Chair
 whether the ballot goes forward to another member ballot, or back to committee ballot.
 Comment · Co-chairs and Editors need a working knowledge of “substantive change” as defined on the Arb website.·

 What Reconciliation Documentation Should Be Retained?
 Issue · By-Laws Section 14.04.01 states: “All comments accompanying affirmative ballots shall be considered by the Technical Committee.” This means each line item must be reviewed. Y
 disposition "considered" to mark affirmative comments that have been reviewed. Committees are encouraged to include in the comment section what they thing of the affirmative comment a


42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Co-Chair Guidelines]                         92                                                                              March 2003
                                                                 V3 Ballot Submission/Resolution Form

 disposition "considered" to mark affirmative comments that have been reviewed. Committees are encouraged to include in the comment section what they thing of the affirmative comment a
 they think action should be taken, and by who.
 Response ·
 Comment


 How do you handle negatives without comment?
 Issue How do you handle a negative ballot is submitted without comments?
 Response The co-chair attempts to contact the voter, indicating “x” days to respond. If there is no response, the vote becomes 'not persuasive' and the co-chair must notify the ballotter of this


 Appeals
 Issue How are appeals handled?
 Response · Negative votes could be appealed to the TSC or Board· Affirmative votes cannot be appealed
 Comment

 Some information is not being retained
 Issue · The disposition of the line item as to whether or not a change request has been accepted needs to be retained. · The status of the line item as it pertains to whether or not the respondent
 the line item is a separate matter and needs to be recorded in the column titled "withdrawn'

 Some information is not being retained
 Issue By-Laws Section 14.04.01 states: “All comments accompanying affirmative ballots shall be considered by the Technical Committee.”· There is divided opinion as to whether or not Tec
 Committee‟s need to review all line items in a ballot.· Should there be a statement on the reconciliation document noting what the TC decided?
 Response “. . .considered” does not mean the committee has to take a vote on each line item. However, a record needs to be kept as to the disposition. There are other ways to review, e.g. se
 committee for review offline, and then discuss in conference call. The review could be asynchronous, then coordinated in a conference call. The ballot has to get to a level where the committ
 the item. The committee might utilize a triage process to manage line items.
 Comment Action Item: Add to the ballot spreadsheet a checkoff for “considered; this would not require, but does not prohibit, documentation of the relative discussion.

 Withdrawing Negatives
 To withdraw a negative ballot or vote, HQ must be formally notified. Typically, the ballotter notifies HQ in writing of this intent. If, however, the ballotter has verbally expressed the intention
 entire negative ballot in the TC meeting, this intent must be documented in the minutes. The meeting minutes can then be sent via e-mail to the negative voter with a note indicating that this i
 that he/she withdrew their negative as stated in the attached meeting minutes and that their vote will be considered withdrawn unless they respond otherwise within five (5) days.

 The ballotter may also submit a written statement to the TC. The submitter's withdrawal must be documented and a copy retained by the co-chairs and a copy sent to HL7 HQ by email or fax.

 Two weeks (14 days) prior to the scheduled opening of the next ballot, the co-chairs must have shared the reconciliation package or disposition of the negative votes with the negative balloter
 balloters then have 7 days to withdraw their negative vote. If, 7 days prior to the scheduled opening of the next ballot the negative vote is not withdrawn, it will go out
 with the subsequent ballot as an outstanding negative.


 Changes applied are not mapped to a specific response
 Issue Changes are sometimes applied to the standard that are not mapped directly to a specific ballot response , due to editing requirements
 Response: A column to record substantive changes and to track whether the change has been applied was added.


42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Co-Chair Guidelines]                           93                                                                               March 2003
                                                                 V3 Ballot Submission/Resolution Form

 Response: A column to record substantive changes and to track whether the change has been applied was added.

 Asking for negative vote withdrawal:
 Please include the unique ballot ID in all requests to ballot submitters. E.g. if asking a ballot submitter to withdraw a negative please use the ballot ID to reference the ballot.


 The following sections contain known outstanding issues. These have not been resolved because they require a 'ruling' on interpretations of the Bylaws and the Policies and Procedures
 updating of those documents. If you ever in doubt on how to proceed on an item, take a proposal for a method of action, then take a vote on that proposal of action and record it in the sp
 the minutes.

 Tracking duplicate ballot issues is a challenge
 Issue Multiple voters submit the same ballot item.
 Response While items may be “combined” for purposes of committee review, each ballot must be responded to independently.
 Comment


 Editorial license
 Issue There is divided opinion as to the boundaries of "editorial license".
 Response
 Comment


 Divided opinion on what requires a vote
 Issue
 Response · Do all negative line items require inspection/vote of the TC? – Yes, but you can group· Do all substantive line items require inspection/vote of the TC? Yes· How should non
 be evaluated for potential controversy that would require inspection and vote of the TC? Prerogative of Chair, if so empowered
 Comment


 Ballet Reconciliation Process Suggestion
 Issue It might be useful to map the proposed change to the ARB Substantive Change document. This would involve encoding the ARB document and making allowances for “Guideline Not F
 Response ARB is updating their Substantive Change document; this process might elicit additional changes.
 Comment Action Item? This would require an additional column on the spreadsheet

 How are line item dispositions handled?
 Issue Line items are not handled consistently
 Response · A Withdrawn negative is counted as an affirmative (this is preferable to non-persuasive.)· A Not related remains negative in the ballot pool for quorum purposes, but does not imp
 e.g. it does not count as a negative in the 90% rule.· A Not persuasive remains negative in the ballot pool for quorum purposes, but does not impede the ballot, e.g. it does not count as a negat
 rule.· Every negative needs a response; not every negative needs to be “I agree with your proposed change.” The goal is to get enough negatives resolved in order to get the ballot to pass, wh
 quality standard.
 Comment

 How should negative line items in an “Affirmative Ballot” be handled?

42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Co-Chair Guidelines]                           94                                                                                March 2003
                                                                 V3 Ballot Submission/Resolution Form


 How should negative line items in an “Affirmative Ballot” be handled?
 Issue Affirmative Ballots are received that contained negative line items. The current practice is to err on the side of caution and treat the negative line item as a true negative (i.e. negative ba
 Response · If a member votes “Affirm with Negative line item” the negative line item is treated as a comment but the ballot overall is affirmative.· Action Item: This must be added to the Ba
 Comment Revising the ballot spreadsheet to eliminate invalid responses will minimize this issue. Note on the ballot spread

 Difference Between Withdraw and Retract
 If a ballot submitter offers to withdraw the negative line item the „negative‟ still counts towards the total number of affirmative and negative votes received for the ballot (as it currently seems
 bylaws). If the submitter offers to retract their negative then it does not count towards the overall affirmative and negative votes received for the ballot.




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Co-Chair Guidelines]                           95                                                                                March 2003
                                                                 V3 Ballot Submission/Resolution Form




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Co-Chair Guidelines]                    96                    March 2003
                                                                                V3 Ballot Submission/Resolution Form


, or replaced by use cases)


lots returned on unmarked items will be found

etation of “obvious error” as you do not want to

ing content. In the early stages of committee
uire two levels of ballot for new content (refer



       persuasive.· In all cases, the voter must

does not make sense to declare non-persuasive
nce you have adopted their recommended




to vote.· Out of scope items




management tool. Question will be removed.

ive with comment – typonaffirmative with




ws 15.07.03). The TSC Chair will determine




ne item must be reviewed. You can use the
of the affirmative comment and whether or not


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                                                                                 V3 Ballot Submission/Resolution Form

 of the affirmative comment and whether or not




 ust notify the ballotter of this disposition.




whether or not the respondent has withdrawn



 nion as to whether or not Technical

e other ways to review, e.g. send to the
 to a level where the committee could vote on




erbally expressed the intention to withdraw the
 th a note indicating that this is confirmation
hin five (5) days.

nt to HL7 HQ by email or fax.

otes with the negative balloters. The negative




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                                                                                V3 Ballot Submission/Resolution Form




 the Policies and Procedures as well as
 action and record it in the spreadsheet and in




C? Yes· How should non-substantive changes




owances for “Guideline Not Found”.




m purposes, but does not impede the ballot,
g. it does not count as a negative in the 90%
er to get the ballot to pass, while producing a




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                                                                                 V3 Ballot Submission/Resolution Form



 true negative (i.e. negative ballot).
 This must be added to the Ballot Instruction



he ballot (as it currently seems to state in the




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                                                                 V3 Ballot Submission/Resolution Form




42013a2b-6e8e-44ff-9743-7cf67c220bbe.xls [Co-Chair Guidelines]                   101                    March 2003
Ballot Committee Code   Ballot Committee Name Ballot Code Name

InM                     Infrastructure and      CT
                        Messaging               XML-ITS DataTypes

                                                XML-ITS Structures

                                                Datatypes Abstract
                                                MT
                                                TRANSPORT
                                                UML-ITS DataTypes

                                                CI, AI, QI
                                                MI

CBCC                    Community Based         MR
                        Collaborative Care


CDS                     Clinical Decision Support DS

CS                      Clinical Statement      CS

FM                      Financial Management    AB
                                                CO
                                                CR

II                      Imaging Integration     DI
                                                II

M and M                 Modelling and           RIM
                        Methodology             Refinement
                                                CPP
                                                MIF
                                                HDF

MedRec                  Medical Records (now    MR
                        merged with SD)

OO                      Orders and Observations BB
                                                CG
                                                CP
                                                LB
                                                ME
                                                OB
                                                OR
                                                RX
                                                SP
                                      TD


PA           Patient Administration   PA
                                      MM
                                      SC

PC           Patient Care             PC

PM           Personnel Management     PM

PHER         Public Health /          IZ
             Emergency Response       PH
                                      RR

Publishing   Publishing               V3 Help Guide (ref)
                                      Backbone (ref)

RCRIM        Regulated Clinical Research Information Management
                                      RP
                                      RT

Sched        Scheduling               SC

StructDocs   Structured Documents     CD
                                      QM

Vocab        Vocabulary               Vocabulary (ref)
                                      Glossary (ref)

ArB          Architectural Review Board
Attach       Attachments
CCOW         Clinical Context Object Workgroup
Ed           Education
Meaning

Version 3: (CMET) Common Message Elements, Release 1, 2, 3
Version 3: XML Implementation Technology Specification - Data Types, Release
1
Version 3: XML Implementation Technology Specification - Structures, Release 1

Version 3: Data Types - Abstract Specification, Release 1
Version 3: Shared Messages, Release 1, 2
Version 3: Transport Protocols
Version 3: UML Implementation Technology Specification - Data Types, Release
1
Version 3: Infrastructure Management, Release 1
Version 3: Master File/Registry Infrastructure, Release 1

Version 3: Medical Records: Composite Privacy Consent Directive, Release 1


Version 3: Clinical Decision Support, Release 1

Version 3: Clinical Statement Pattern, Release 1

Version 3: Accounting and Billing, Release 1,2
Version 3: Coverage, Release 1 (virtual CMET domain)
Version 3: Claims and Reimbursement, Release 1, 2, 3, 4

Version 3: Diagnostic Imaging, Release 1
Version 3: Imaging Integration, Release 1

Version 3: Reference Information Model, Release 1, 2
Version 3: Refinement, Extensibility and Conformance, Release 1, 2
Version 3: Core Principles and Properties
Version 3: Model Interchange Format
Version 3: HL7 Development Framework, Release 1

Version 3: Medical Records, Release 1, 2


Version 3: Blood Tissue Organ, Release 1
Version 3: Clinical Genomics, Release 1
Version 3: Common Product Model, Release 1
Version 3: Laboratory, Release 1
Version 3: Medication, Release 1
Version 3: Observations, Release 1
Version 3: Orders, Release 1
Version 3: Pharmacy, Release 1
Version 3: Specimen, Release 1
Version 3: Therapeutic Devices, Release 1


Version 3: Patient Administration, Release 1, 2
Version 3: Material Management, Release 1
Version 3: Scheduling, Release 1

Version 3: Care Provision, Release 1

Version 3: Personnel Management, Release 1

Version 3: Immunization, Release 1
Version 3: Public Health, Release 1
Version 3: Regulated Reporting, Release 1

Version 3: Guide
Version 3: Backbone

Version 3: Regulated Products, Release 1
Version 3: Regulated Studies, Release 1

Version 3: Scheduling, Release 1, 2

Version 3: Clinical Document Architecture, Release 1, 2
Version 3: Quality Measures, Release 1

Version 3: Vocabulary
Version 3: Glossary
Type of Document

Domain

Foundation

Foundation
Foundation
Domain
Foundations

Foundation
Domains
Domain



Domain

Domain

Domain

Domain
Domain
Domain

Domain
Domain

Foundation
Foundation
Foundation
Foundation
Foundation



Domain

Domain
Domain
Domain
Domain
Domain
Domain
Domain
Domain
Domain
Domain



Domain
Domain
Domain

Domain

Domain

Domain
Domain
Domain

Reference
Reference

Domain
Domain

Domain

Domain
Domain

Foundation
Reference
                                                            V3 Ballot Submission/Resolution Form

This page reserved for HL7 HQ. DO NOT EDIT.




                      Affirmative Negative



If you submit an overall affirmative vote, please make sure you have not included negative line items on the Ballot worksheet
Please be sure that your overall negative vote has supporting negative comments with explanations on the Ballot worksheet
You have indicated that you will be attending the Working Group Meeting and that you would like to discuss at least one of your comments with the responsible Committee during that time. Ple




Yes                   No


                                                                              Consi Consi            Pendi Pendi
                                                                              dered - dered -        ng      ng
                                                                     Consider No      Questi         input input
                                                                     ed for   action on              from from
                      Persuasive Not      Not persuasive     Not     future   requir Answe           submit other
Persuasive            with mod persuasive with mod           related use      ed      red            ter     WG
                                                                                              Referred and tracked

HD
AR
RM
IN
TE
MT
DM
ST
??




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                                                   V3 Ballot Submission/Resolution Form

                                                        ArB,Ard
                                                        en,Attac
                                                        h,Cardio
                                                        ,CBCC,
                                                        CCOW,
                                                        CDS,CG
                                                        ,CIC,Clin
                                                        ical
                                                        Stateme
                                                        nt,Confo
                                                        rm,Ed,E
                                                        HR,FM,II
                                                        ,Implem
                                                        entation,
                                                        InM,ITS,
                                                        Lab,M
                                                        and M,M
                                                        and M/
                                                        CMETs,
                                                        M and
                                                        M/
                                                        Templat
                                                        es,M
                                                        and M/
                                                        Tooling,
                                                        MedRec,
                                                        OO,PA,
                                                        PC,PHE
                                                        R,PM,P
                                                        S,PSC,
                                                        RCRIM,
                                                        RX,Sche
                                                        d,Securit




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                                                                           V3 Ballot Submission/Resolution Form




Committee during that time. Please note that due to time constraints not all comments can be reviewed at WGMs and that it is your responsibility to find out when this ballot comment can be scheduled for dis




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                                                   V3 Ballot Submission/Resolution Form




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omment can be scheduled for discussion.




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