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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:
Enter Ballot Comments (Line Items) Instructions
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Submitter] 1 March 2003
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:
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Submitter] 2 March 2003
V3 Ballot Submission/Resolution Form
Ballot Comment Submission
Vote
and
Number Ballot WG Artifact Artifact ID Chapter Section Pubs Type Existing Wording Proposed Wording
1 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).
2 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).
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 3 March 2003
V3 Ballot Submission/Resolution Form
3 5.27 Result Neg-Mj 7. SHALL contain exactly one [1..1]
Observatio statusCode/@code="completed"
n Completed
4 StructDocs ?? CDAR2_IG_C Cover Cover Yes Neg-Mi Identify as DSTU
ONSOL_R1_
D1_2011APR
5 StructDocs ?? CDAR2_IG_C All All No Neg-Mj Meaningful Use Global replace: Stage 1 Meaningful
ONSOL_R1_ Use
D1_2011APR
6 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”
7 StructDocs ?? CDAR2_IG_C 1 1.9 No Neg-Mj Table 1 Add column for ballot applicability.
ONSOL_R1_
D1_2011APR
8 StructDocs ?? CDAR2_IG_C 2 2.1 No Neg-Mi Table 3
ONSOL_R1_
D1_2011APR
9 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
10 StructDocs ?? CDAR2_IG_C 2 2.1.1 No A-C
ONSOL_R1_
D1_2011APR
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 4 March 2003
V3 Ballot Submission/Resolution Form
11 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
12 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
13 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).
14 StructDocs ?? CDAR2_IG_C 2 2.1.1 No Neg-Mi Table 11 Remove
ONSOL_R1_
D1_2011APR
15 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) .
16 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
17 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).
18 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.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 5 March 2003
V3 Ballot Submission/Resolution Form
19 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…)
20 StructDocs ?? CDAR2_IG_C 2 2.2 No Neg-Mi Table 15 Add "HP" for primary home.
ONSOL_R1_
D1_2011APR
21 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.
22 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.
23 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.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 6 March 2003
V3 Ballot Submission/Resolution Form
24 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).
25 StructDocs ?? CDAR2_IG_C Appendix B Appendix No Neg-Mj Change log not precise enough
ONSOL_R1_ B
D1_2011APR
26 StructDocs ?? CDAR2_IG_C 4 4.19 Yes A-T Hopsital Course Hospital Course
ONSOL_R1_
D1_2011APR
27 StructDocs ?? CDAR2_IG_C 1 1.7.6 No A-C Null flavors
ONSOL_R1_
D1_2011APR
28 StructDocs ?? CDAR2_IG_C General No Neg-Mi
ONSOL_R1_
D1_2011APR
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 7 March 2003
V3 Ballot Submission/Resolution Form
29 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"
30 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.
31 StructDocs ?? CDAR2_IG_C 4 4.10 No Neg-Mj
ONSOL_R1_
D1_2011APR
32 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.
33 StructDocs ?? CDAR2_IG_C 4 4.40 No Neg-Mi
ONSOL_R1_
D1_2011APR
34 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.
35 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
36 StructDocs ?? CDAR2_IG_C General Yes A-S
ONSOL_R1_
D1_2011APR
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 8 March 2003
V3 Ballot Submission/Resolution Form
37 StructDocs ?? CDAR2_IG_C 4 4.50 No Neg-Mj CONF:7113 SHALL contain exactly
ONSOL_R1_ one Result organizer
D1_2011APR
38 StructDocs ?? CDAR2_IG_C 4 4.28 No Neg-Mi
ONSOL_R1_
D1_2011APR
39 StructDocs ?? CDAR2_IG_C 4 4.35 No Neg-Mi Plan Section Plan of Care Section
ONSOL_R1_
D1_2011APR
40 StructDocs ?? CDAR2_IG_C 4 4.56 No Neg-Mi CONF:7277 SHALL contain exactly
ONSOL_R1_ one Vital Signs organizer
D1_2011APR
41 StructDocs ?? CDAR2_IG_C General No A-T SNOMEDCT, SNOMED CT,
ONSOL_R1_ SNOMED-CT
D1_2011APR
42 StructDocs ?? CDAR2_IG_C 1 1.7.4 and No Neg-Mi
ONSOL_R1_ constraints
D1_2011APR containing
"such that
it…"
43 StructDocs ?? CDAR2_IG_C 5 5.20 No Neg-Mi
ONSOL_R1_ Problem
D1_2011APR Status
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 9 March 2003
V3 Ballot Submission/Resolution Form
44 StructDocs ?? CDAR2_IG_C 1.7.2 No Neg-Mi
ONSOL_R1_ Conformance
D1_2011APR Statements
45 StructDocs ?? CDAR2_IG_C General No Neg-Mi
ONSOL_R1_
D1_2011APR
46 StructDocs ?? CDAR2_IG_C 5 5.2 Alert No Neg-Mj
ONSOL_R1_ Status
D1_2011APR Observatio
n
47 StructDocs ?? CDAR2_IG_C 5 5.3 Allergy No Neg-Mj
ONSOL_R1_ Problem
D1_2011APR Act
48 StructDocs ?? CDAR2_IG_C 5 5.5 No Neg-Mi
ONSOL_R1_ Condition
D1_2011APR
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 10 March 2003
V3 Ballot Submission/Resolution Form
49 StructDocs ?? CDAR2_IG_C 5 5.18 No Neg-Mi
ONSOL_R1_ Medication
D1_2011APR Use - None
Known
50 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).
51 StructDocs 1.7 A-C none an explanation of "optional entries"
vs. "required entries"
52 1.7.4 A-Q Figure 3- example of "only one like an example that is representative
this allowed".
53 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
54 2.1.2 Neg-Mj missing assignedAuthoringDevice inclusion of these statements-
and representedOrganization directly or in reference
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 11 March 2003
V3 Ballot Submission/Resolution Form
55 2.1.7 Neg-Mi This assignedEntity SHALL contain This assignedEntity SHOULD
exactly one assignedPerson contain exactly one assignedPerson.
(CONF:5597)
56 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.
57 2.1 Neg-Mj no "support" / "Patient Contacts" inclusion of template for Patient
module equivalents Contacts / "Support"
58 2.1 Neg-Mj no "documentationOf" conformance inclusion of documentationOf
statements statements
59 2.4 Neg-Mj no "performer" statements within inclusion of performer statements
serviceEvent
60 2.4 A-S "use serviceEvent/effectiveTime/low
with a width element"
61 3.1.1.3 A-S
62 3.1.2 A-T "The Continuity of Care Document …requiring coded…
supports both narrative sections and
sections requiring code clinical
statements"
63 3.8 A-T "A progress Note is not a revaluation …not a re-evaluation note
note"
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 12 March 2003
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64 3.9 A-T 3rd paragraph: "…such as a word- …"word-processing"
proccesing document"
65 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…"
66 4 A-S inclusion of a description of the
narrative block.
67 4.2 A-S "Optional Entries" "Template for Entries Being
optional"
68 4.2 A-S "Required Entries" "Template for Entries Being
Required"
69 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"
70 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).
71 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).
72 4.19 A-T "Hopsital Course Section" "Hospital Course Section"
73 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)."
74 4.28 A-S "Optional Entries" "Template for Entries Being
optional"
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 13 March 2003
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75 4.28 A-S "Required Entries" "Template for Entries Being
Required"
76 4.2 Neg-Mj missing implementation of inclusion of directions for
documentation of NKDA/NKA. documentation of NKDA/NKA
77 4.4 Neg-Mj missing implementation of inclusion of directions for
documentation of No known documentation of No Known
Problems Problems
78 4.48 Neg-Mj missing implementation of inclusion of directions for
documentation of No Procedures documentation of No Procedures
79 4.50 Neg-Mj missing implementation of inclusion of directions for
documentation of No Results documentation of No Results
80 4.40 A-C UML Diagram
81 4.48 A-S "Optional Entries" "Template for Entries Being
optional"
82 4.48 A-S "Required Entries" "Template for Entries Being
Required"
83 4.50 A-S "Optional Entries" "Template for Entries Being
optional"
84 4.50 A-S "Required Entries" "Template for Entries Being
Required"
85 4.56 A-S "Optional Entries" "Template for Entries Being
optional"
86 4.56 A-S "Required Entries" "Template for Entries Being
Required"
87 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.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 14 March 2003
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88 5.25 Neg-Mj conformance statement #4, "SHALL value set not defined
contain exactly one…code"
89 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
90 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.
91 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.
92 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.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 15 March 2003
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93 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.
94 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.
95 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.
96 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.
97 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.
98 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).
99 StructDocs ?? Document 2 General A-Q CONF-HP-23: Shall contain
Templates Header [1..1]effectiveTime
Constraints
-
100 StructDocs 3 3.0 A-S Table 18 - Optional Sections
Document
Level
Template -
Table 18 -
CCD
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 16 March 2003
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101 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.
102 StructDocs 3 3.8.1.2 A-S
ClinicalDo
cument/Co
de: Table
29
103 StructDocs 4 Table 31 A-S Allergies and Other Adverse
Reactions
104 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.
105 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).
106 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
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 17 March 2003
V3 Ballot Submission/Resolution Form
107 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
108 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).
109 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
110 StructDocs 5 5.4 Neg-Mi Table 39: Ingredient Name Value Set
Allergy/Ale
rt
Observatio
n
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 18 March 2003
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111 StructDocs General General Neg-Mj
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 19 March 2003
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112 StructDocs General Neg-Mj
113 StructDocs General Neg-Mj
114 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.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 20 March 2003
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115 StructDocs General General Neg-Mj
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 21 March 2003
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116 StructDocs General Neg-Mj
117 StructDocs General Neg-Mj
118 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.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 22 March 2003
V3 Ballot Submission/Resolution Form
119 StructDocs Table 11: Neg-Mj
State Value
Set
120 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.
121 StructDocs 5.26.5.a A-S Suggest add:
Regional codes for laboratory results
SHOULD also be allowed.
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V3 Ballot Submission/Resolution Form
122 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.
123 StructDocs 5.27.5.a A-S Suggest add:
Regional codes for laboratory results
SHOULD also be allowed.
124 StructDocs 5.27.4 and A-Q
5.27.5
125 StructDocs 4.23 and A-Q
4.50
126 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.
127 StructDocs ?? 2.2 Neg-Mi SHALL not have mixed content ??
128 StructDocs ?? 2.3 Neg-Mi SHALL not have mixed content ??
129 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
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130 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
131 StructDocs ?? 5.5 Neg-Mi same as 5.3
132 StructDocs ?? 5.25 Neg-Mj 10. SHOULD contain exactly one
[1..1] entrRelationship (CONF:7580)
such that it
133 StructDocs ?? 5.29 Neg-Mj This clinical statement represents the
severity of the reaction to an agent.
134 StructDocs
135 StructDocs Neg-Mi
136 StructDocs 5.2, 5.11, Neg-Mj
5.20
137 StructDocs 5.30. Neg-Mj
138 StructDocs 5.31 Neg-Mj
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139 StructDocs 4.2, 4.28, Neg-Mj
4.48, 4.50,
4.56
140 StructDocs 5.14 Neg-Mj
141 StructDocs All Neg-Mj
142 StructDocs 3 Document No A-Q
type -
Discharge
Summary
143 StructDocs 4 4.13 No A-C
144 StructDocs 4 4.18 No A-C
145 StructDocs 4 4.45 No A-Q
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 26 March 2003
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146 StructDocs 1.7.2 A-S
147 StructDocs 1.7.6 A-S
148 StructDocs 1.8.1 A-S
149 StructDocs 1.8.3 A-S
150 StructDocs 1.9 A-S
151 StructDocs 2.1 Neg-Mi
152 StructDocs 2.1 A-Q
153 StructDocs 2.1.1 Neg-Mi
154 StructDocs 3.1 A-S
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 27 March 2003
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155 StructDocs passim A-S
156 StructDocs 5.4 Neg-Mi
157 StructDocs 5.3 A-T
158 StructDocs 4.13 A-Q
159 StructDocs 4.19 A-T
160 StructDocs passim A-Q
161 StructDocs 4.24 A-S
162 StructDocs 4.40 A-S
163 StructDocs passim A-S
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 28 March 2003
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164 StructDocs 1.5 A-S
165 StructDocs passim A-S
166 StructDocs 5.31 A-Q
167 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.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 29 March 2003
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168 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.
169 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
170 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.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 30 March 2003
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171 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.
172 StructDocs All Neg-Mi
173 StructDocs All Neg-Mi
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 31 March 2003
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174 StructDocs 3.2.1.2 A-S Use of these codes is not
recommended, as this duplicates
information potentially present in the
header
175 StructDocs All A-S
176 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
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 32 March 2003
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177 StructDocs Progress_Note All Neg-Mi
.xml
178 StructDocs 4.1 A-S 6. MAY contain exactly one [1..1]
Advance entry (CONF:7957)
Directives
Section
42348-3
179 StructDocs CDAR2_IG_C 2.1 Neg-Mi
ONSOL_R1_
D1_2011APR
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 33 March 2003
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180 StructDocs CDAR2_IG_C 2.1 A-S
ONSOL_R1_
D1_2011APR
181 StructDocs CDAR2_IG_C 2.1 A-S
ONSOL_R1_
D1_2011APR
182 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
183 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
184 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)
185 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)
186 StructDocs CDAR2_IG_C 2.4 A-S When you know only the date ...
ONSOL_R1_ However, if you know the date ...
D1_2011APR
187 StructDocs CDAR2_IG_C 2.4 1 Neg-Mj SHOULD contain exactly one [1..1]
ONSOL_R1_ serviceEvent/@classCode="PCPR"
D1_2011APR
188 StructDocs CDAR2_IG_C 3 Table 18 Neg-Mi Required Sections | Optional
ONSOL_R1_ Sections
D1_2011APR
189 StructDocs CDAR2_IG_C 3 Table 18 Neg-Mi
ONSOL_R1_
D1_2011APR
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 34 March 2003
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190 StructDocs CDAR2_IG_C 3 Table 18 Neg-Mi Procedures (6)
ONSOL_R1_ (6) Required only for inpatient
D1_2011APR settings
191 StructDocs CDAR2_IG_C 3 Table 18 Neg-Mi Diagnostic Imaging Report /
ONSOL_R1_ Findings (Radiology Comparison
D1_2011APR Study - Observation)
192 StructDocs CDAR2_IG_C 3 Table 18 Neg-Mi Diagnostic Imaging Report /
ONSOL_R1_ Radiology - impression
D1_2011APR
193 StructDocs CDAR2_IG_C 3 Table 18 Neg-Mi Procedure Note /
ONSOL_R1_ Plan of Care
D1_2011APR
194 StructDocs CDAR2_IG_C 3 Table 18 Neg-Mi Procedure Note /
ONSOL_R1_ Procedure Disposition
D1_2011APR
195 StructDocs CDAR2_IG_C 3 Neg-Mj <templateID>
ONSOL_R1_
D1_2011APR
196 StructDocs CDAR2_IG_C 3.1 A-S C32 HITSP C32
ONSOL_R1_
D1_2011APR
197 StructDocs CDAR2_IG_C 3.2.1.2 Table 19 A-S
ONSOL_R1_
D1_2011APR
198 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
199 StructDocs CDAR2_IG_C 3.3.1 1 Neg-Mj Conforms to US Realm Clinical
ONSOL_R1_ Document Header Template
D1_2011APR
200 StructDocs CDAR2_IG_C 3.3.1.5 A-T inFullfillmentOf inFulfillmentOf
ONSOL_R1_
D1_2011APR
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 35 March 2003
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201 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
202 StructDocs CDAR2_IG_C 3.7 1 Neg-Mj Conforms to Consolidated US Realm
ONSOL_R1_ Header Template
D1_2011APR
203 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)
204 StructDocs CDAR2_IG_C 3.7 Neg-Mi
ONSOL_R1_
D1_2011APR
205 StructDocs CDAR2_IG_C 4 A-S
ONSOL_R1_
D1_2011APR
206 StructDocs CDAR2_IG_C 4.10 4 Neg-Mi SHALL NOT contain [0..0] title
ONSOL_R1_
D1_2011APR
207 StructDocs CDAR2_IG_C 4.10 5 Neg-Mi SHALL NOT contain [0..0] text
ONSOL_R1_
D1_2011APR
208 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
209 StructDocs CDAR2_IG_C 4.40 Neg-Mi SHOULD contain a case-insensitive
ONSOL_R1_ language-insensitive string
D1_2011APR containing 'problems'.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 36 March 2003
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210 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
211 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)
212 StructDocs
213 StructDocs General Change Yes Neg-Mj
Log
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 37 March 2003
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214 StructDocs General Substantiv
e Changes
215 StructDocs 1.7.2 Neg-Mi
Conformance
Statements
216 StructDocs 1.7.2 Neg-Mj
Conformance
Statements
217 StructDocs 1.7.2 A-S
Conformance
Statements
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 38 March 2003
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218 StructDocs 1.7.2 A-S
Conformance
Statements
219 StructDocs 1.7.5 Neg-Mj
Vocabulary
Conformance
220 StructDocs 1.7.5 Neg-Mi
Vocabulary
Conformance
221 StructDocs 1.7.2 Neg-Mi
Conformance
Statements
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 39 March 2003
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222 StructDocs 1.7.2 Neg-Mi
Conformance
Statements
223 StructDocs 1.7.2 A-S
Conformance
Statements
224 StructDocs 1.7.2 Neg-Mi
Conformance
Statements
225 StructDocs Neg-Mj
226 StructDocs Neg-Mi
227 StructDocs Neg-Mj
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 40 March 2003
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228 StructDocs Neg-Mj
229 StructDocs Neg-Mj
230 StructDocs Neg-Mj
231 StructDocs Neg-Mj
232 StructDocs Neg-Mj
233 StructDocs Neg-Mj
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 41 March 2003
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234 StructDocs Neg-Mi
235 StructDocs Neg-Mj
236 StructDocs Neg-Mj
237 StructDocs Neg-Mi
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 42 March 2003
V3 Ballot Submission/Resolution Form
238 StructDocs Section 2.2 Neg-Mj
US Realm
Clinical
Document
Header
Address
239 StructDocs Section 2.2 Neg-Mi
US Realm
Clinical
Document
Header
Address
240 StructDocs Section 2.3 Neg-Mj
US Realm
Clinical
Document
Name
241 StructDocs Section 2.3 Neg-Mi
US Realm
Clinical
Document
Name
242 StructDocs Advance Neg-Mj
Directives
Section
243 StructDocs Allergies and A-T
Adverse
Reaction
Section
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 43 March 2003
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244 StructDocs Allergies and Neg-Mj
Adverse
Reaction
Section
245 StructDocs Allergies and A-S
Adverse
Reaction
Section
246 StructDocs Allergies and Neg-Mi
Adverse
Reaction
Section
247 StructDocs Allergy Neg-Mj
Observation
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 44 March 2003
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248 StructDocs Allergy Neg-Mj
Observation
249 StructDocs Problem Neg-Mj
Status
250 StructDocs Allergy Neg-Mj
Problem Act
251 StructDocs Allergy Neg-Mj
Problem Act
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 45 March 2003
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252 StructDocs Condition Neg-Mj
253 StructDocs Condition A-T
254 StructDocs Condition Neg-Mi
Entry
255 StructDocs Condition Neg-Mi
Entry
256 StructDocs Medication Neg-Mj
257 StructDocs Text Neg-Mj
References
258 StructDocs Text Neg-Mj
References
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 46 March 2003
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259 StructDocs Medication Neg-Mj
260 StructDocs Medication Neg-Mj
Supply Order
261 StructDocs Medication Neg-Mi
Supply Order
262 StructDocs Medication Neg-Mi
Dispense
263 StructDocs Medication Neg-Mj
Use None
Known
264 StructDocs ?? 2.1.1 Yes A-C reference to "US Realm Clinical
Document Header Address"
265 StructDocs ?? 2.1.1; A-Q administrativeGenderCode/@cod
Table 5 e, which SHALL be selected from
ValueSet … Administrative
Gender (HL7 V3)
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 47 March 2003
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266 StructDocs ?? 2.1.1; A-C birthTime
12.a.iv.3
267 StructDocs ?? 2.4; 3.a A-C The serviceEvent/effectiveTime The serviceEvent/effectiveTime
element SHALL be accurate to the element SHALL be accurate to the
day, and MAY be accurate to the day, and MAY be accurate to the
second. (CONF:7602) second and MAY include GMT
offset. If no offset indicated, then
an offset of 0 is assumed.
(CONF:7602)
268 3.1.1.4 A-T Item numbering uses a "1" Should be a "5" because it flows
from previous sections?
269 3.1.2 Neg-Mi This should read similar to section
3.2.2--"SHALL contain exactly one
[1…1] component" and "can have
either a structuredBody or a
nonXMLBody.
270 3.2.2 A-T A History and Physical document A Consultation Note document can
can conform to CDA Level 1 conform to CDA Level 1
(nonXMLBody)… (nonXMLBody)…
271 3.2.2 Neg-Mi A History and Physical document
can conform to CDA Level 1
(nonXMLBody), CDA Level 2
(structuredBody with sections that
contain a narrative block), or CDA
Level 3 (structuredBody containing
sections that contain a narrative
block and coded entries). This Guide
provides separate templateIds for
documents in which coded entries
are required and for documents in
which coded entries are optional. In
this template (templateId
2.16.840.1.113883.10.20.22.1.4),
coded entries are optional.
(CONF:8399).
272 3.2.1.3; A-T A special class of participant is the A special class of participant is the
4.b. supporting person or organization: supporting person or organization:
an individual or an organization that an individual or an organization that
has a relationship to the patient, has a relationship to the patient,
including including parents, including parents, relatives,
relatives, caregivers, insurance caregivers, insurance policyholders,
policyholders, and guarantors. and guarantors.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 48 March 2003
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273 3.3.1.3; A-T <code code="18748-4" <code code="18748-4"
Figure 19 codeSystem="2.16.840.1.113883.6.1 codeSystem="2.16.840.1.113883.6.
" 1"
codeSystemName="LOINC" codeSystemName="LOINC"
displayName="Diagnostic displayName="Diagnostic
Imaging Report” Imaging Report” >
<translation code='XRPEDS' <translation code='XRPEDS'
displayName='Pediatric displayName='Pediatric
Radiography Report' Radiography Report'
codeSystem='2.16.840.1.123456.78. codeSystem='2.16.840.1.123456.78.
9'/> 9'/>
</code> </code>
274 3.3.2 Neg-Mi This should read similar to section
3.2.2--"SHALL contain exactly one
[1…1] component" and "can have
either a structuredBody or a
nonXMLBody, etc.
275 3.4.1.4; A-Q 1. The dischargeDispositionCode
1.a.iii.1 SHALL be displayed when the
document is rendered.
(CONF:8477).
276 3.4.2 Neg-Mi This should read similar to section
3.2.2--"SHALL contain exactly one
[1…1] component" and "can have
either a structuredBody or a
nonXMLBody, etc.
277 3.6.2 Neg-Mi This should read similar to section
3.2.2--"SHALL contain exactly one
[1…1] component" and "can have
either a structuredBody or a
nonXMLBody, etc.
278 3.7.2 Neg-Mi This should read similar to section
3.2.2--"SHALL contain exactly one
[1…1] component" and "can have
either a structuredBody or a
nonXMLBody, etc.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 49 March 2003
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279 3.8.2 Neg-Mi This should read similar to section
3.2.2--"SHALL contain exactly one
[1…1] component" and "can have
either a structuredBody or a
nonXMLBody, etc.
280 3.9.2 A-C
281 4.0 Neg-Mi
282 4.20; 2 A-T 2. SHALL contain exactly one [1..1]
code/@code="48765-2" Allergies,
adverse reactions, alerts
(CodeSystem:
2.16.840.1.113883.6.1 LOINC)
(CONF:7980).
283 4.40; Neg-Mi
Required
Entries
284 4.40; Neg-Mi 2. SHOULD contain zero or more 2. SHALL contain one or more
Required [0..*] entry (CONF-CONSOL-549), [1..*] entry (CONF-CONSOL-549),
Entries; 2
285 5.4 Neg-Mi 5. SHALL contain exactly one [1..1]
code, which SHALL be selected
from ValueSet
2.16.840.1.113883.3.88.12.3221.6.2
Allergy/Adverse Event Type
DYNAMIC (CONF:7383).
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 50 March 2003
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286 5.4; 8.a.i.1 Neg-Mi 1. A reference/@value SHOULD
point to its corresponding narrative
(using the approach defined in CDA
Release 2, section 4.3.5.1 ).
(CONF:7401).
287 5.4; Neg-Mi 1. A reference/@value SHOULD
9.b.ii.2.b point to its corresponding narrative
(using the approach defined in CDA
Release 2, section 4.3.5.1 ).
(CONF:7426).
288 5.11; 6 Neg-Mj 6. SHOULD contain exactly one
[1..1] text (CONF-CONSOL-546)
a. The 'text' elements SHOULD
contain a 'reference' element
pointing to the narrative where the
severity is recorded, rather than
duplicate text to avoid ambiguity.
(CONF-CONSOL-544)
289 5.x 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
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V3 Ballot Submission/Resolution Form
290 4.x and 5.x Neg-Mi Details about data types from the
RIM and even the CDA are not
included and clarified in this
document
291 StructDocs 1.5 Neg-Mi Chapter 4. Section-level Templates. Chapter 4. Section-level Templates.
This chapter describes the section- This chapter specifies the section
level constraints for sections templates referenced within the
referenced within the document document types described here.
types described here and which can Sections are atomic units and they
be reused by future specifications. can be reused by future
specifications.
292 StructDocs 1.5 Neg-Mi Chapter 5. Entry-level Templates. Chapter 5. Entry-level Templates.
This chapter specifies the atomic This chapter specifies the entry
units of the report, the entry templates, called clinical statements.
templates, or clinical statements. The entries are the machine-
Machine-processable data is sent in processable data which represent
the entry templates. The entry concepts from the human readable
templates are referenced by section narrative expressed in the associted
templates. section. Entry templates are
referenced by section templates.
Entries are a sub-atomic unit that
can be reused by future
specifications within the context of
other sections.
293 5 Neg-Mj Each section-level template add to the bullet list an item to
description contains the following require that every section contain an
major information: instance id.
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294 3.1 Neg-Mi 3.1.1 - 3.1.8 cover all the add 3.1.9 to cover participant.
participations (RecordTaget,
authenticator, legalAuthenticator,
etc.) except participant.
295 4 table 2. Neg-Mi Document Type in first row shows Document type should be
CCD as the Document Type for Summarization of Episode Note
documents with LOINC code of
34133-9
296 4.4.1.2 Neg-Mi When a patient is discharged from
table 6 the hospital, how many Discharge
Summary CDAs would be expected
to be generated?
297 5 Table 12 Vital Signs templateIds are the same 2.16.840.1.113883.10.20.21.2.4.1
for the Entries Required as the 2.16.840.1.113883.10.20.21.2.4
Entries Optional.
2.16.840.1.113883.10.20.21.2.4
2.16.840.1.113883.10.20.21.2.4
298 StructDocs General 2.3 A-C pg 32
Header Table 17, HL7
Template EntityNamePartQualifier, Code-
DEV Device name.
OID 2.16.840.1.113883.5.43
299 StructDocs Document 3 A-C pg 40 Change medical equipment to a
level Table 18, CCD, OID required section and include the
templates 2.16.840.1.113883.10.20.22.1.2 FDA unique device identification
Optional sections include medical
equipment
300 StructDocs Document 3 A-C pg 40
level Table 18, Consultation Note,
templates Optional sections- lists includes 3
reports (Chief Complaint, Chief
Complaint/Reason for Visit, and
Reason for Visit).
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301 StructDocs Document 3 A-C pg 41
level Table 18, Diagnostic Imaging
templates Report
302 StructDocs Document 3 A-C pg 42 Change implants to a required
level Table 18, Operative note, OID section and include the FDA unique
templates 2.16.840.1.113883.10.20.22.1.7 device identification
Optional sections includes implants
303 StructDocs Document 3 A-C pg 102 Change implants to be required in
level Table 31, Section name- Implants, an operative note and include the
templates LOINC 55122-6, OID FDA unique device identification
2.16.840.1.113883.10.20.22.1.7
Marked as (O) Optional in the
operative note column
304 StructDocs Document 3 A-C pg 103 Change medical equipment to a
level Table 31, Section name- Medical required section in the CCD and
templates equipment, LOINC 46264-8, OID include the FDA unique device
2.16.840.1.113883.10.20.22.2.23 identification
Marked as (O) Optional in the CCD
column
305 StructDocs Document 3 A-C pg 104 Change procedure implants to a
level Table 31, Section name- Medical required section for the procedure
templates equipment, LOINC 59771-6, OID note and include the unique device
2.16.840.1.113883.10.20.22.2.40 identification
Marked as (O) Optional in the
Procedure note column
306 3.3 A-C
Diagnostic
Imaging
Report
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307 4.2 A-C
Allergies,
Adverse
Reactions,
Alerts
section
48765-2
308 StructDocs 4.25 A-C pg 118
Implant Note: This conformance statement is
section for reference only. It has not yet been
55122-6 reviewed and consolidated according
to the scope and intent of this guide.
a. If the Implants section is present,
there SHALL be a statement
providing details of the implants
placed or SHALL explicitly state
there were no implants placed.
309 StructDocs 4.25 A-C pg 118
Implant b. The Implants section may contain
section clinical statements. If present, the
55122-6 clinical statements shall include one
or more supply activities (CCD
templateId
2.16.840.1.113883.10.20.1.34), may
include product instance (CCD
templateId
2.16.840.1.113883.10.20.1.52) and
may include one or more medication
activities (CCD templateId
2.16.840.1.113883.10.20.1.24).
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310 StructDocs 4.26 A-C pg 119
Medical a. NOTE: This conformance
Equipment statement is for reference only. It has
section not yet been reviewed and
46264-8 consolidated according to the scope
and intent of this guide.
CONF-XXXX: The Medical
Equipment section SHOULD
contain clinical statements. Clinical
statements SHOULD include one or
more supply activities (templateId
2.16.840.1.113883.10.20.22.4.17)
and MAY include one or more
medication activities (templateId
2.16.840.1.113883.10.20.22.4.16).
NOTE: This conformance statement
is for reference only. It has not yet
been reviewed and consolidated
according to the scope and intent of
this guide. (CONF:7950).
311 StructDocs 4.45 A-C pg 132 a. The Implants section may contain
Procedure NOTE: This conformance statement clinical statements. If present, the
implants is for reference only. It has not yetclinical statements shall include one
Section been reviewed and consolidated or more CCD Supply activities
59771-6 according to the scope and intent of (templateId
this guide. 2.16.840.1.113883.10.20.1.34),
shall include CCD Product instance
a. The Implants section may contain (templateId
clinical statements. If present, the 2.16.840.1.113883.10.20.1.52), and
clinical statements may include one may include one or more CCD
or more CCD Supply activities Medication activities (templateId
(templateId 2.16.840.1.113883.10.20.1.24).
2.16.840.1.113883.10.20.1.34), may
include CCD Product instance
(templateId
2.16.840.1.113883.10.20.1.52), and
may include one or more CCD
Medication activities (templateId
2.16.840.1.113883.10.20.1.24).
312 StructDocs 1.2 Neg-Mi
Purpose
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313 StructDocs immunizati A-C
on
314 StructDocs 1.3 A-Q When complete, this guide will fully
specify a compliant CDA R2
document for each of document
types. At present, the entry-level
templates cover only those required
for Meaningful Use. The next release
of this guide will include the full set
of entry-level templates used by
CCD, Health Story, and the
corresponding IHE profiles.
315 StructDocs 1.8.2 A-T xmis xmls
316 StructDocs 2.1.1.12.a.i A-S 5. This patient MAY contain zero or MAY contain zero or more
v one [0..1] religiousAffiliationCode,
which SHALL be selected from
ValueSet
2.16.840.1.113883.1.11.19185 HL7
Religious Affiliation DYNAMIC
(CONF:5317).
317 2.1.1.12.a.i A-S 6. This patient MAY contain zero or MAY contain zero or more
v one [0..1] raceCode, which SHALL
be selected from ValueSet
2.16.840.1.113883.1.11.14914 Race
DYNAMIC (CONF:5322).
318 2.1.1.12.a.i A-S 7. This patient MAY contain zero or
v more [0..*] sdwg:raceCode, which
SHALL be selected from ValueSet
2.16.840.1.113883.1.11.14914 Race
DYNAMIC (CONF:7263).
319 2.1.1.12.a.i A-S 9.c. This guardian, if present, SHALL contain one or more
v SHALL contain exactly one [1..1]
telecom (CONF:5382).
320 2.1.1.12.a.i A-S 9. This patient SHOULD contain SHOULD contain zero or more
v zero or one [0..1] guardian
(CONF:5325).
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321 2.1.1 Neg-Mi Current value set uses FIPS 5-2 for Change this Value Set to the
Table 11 the state codes. This has Alabama as standard 2 letter code that everyone
"01", Florida as "12", FEDERATED commonly uses. The official USPS
STATES OF MICRONESIA as "64". list is located at the following site:
http://www.usps.com/ncsc/lookups/
abbr_state.txt
322 3.2.1.3.4.b A-T patient, including including parents, patient, including parents,
323 3.2.2.7.a.i A-T A History and Physical document A Consultation Note document can
can conform conform
324 3.3.1.2.3 A-S a. OIDs SHALL be represented in
dotted decimal notation, where each
decimal number is either 0 or starts
with a nonzero digit. More formally,
an OID SHALL be in the form ([0-
2])(.([1-9][0-9]*|0))+ (CONF:8406).
b. OIDs SHALL be no more than 64
characters in length. (CONF:8407).
325 5 Neg-Mi SHALL contain at least one [1..*] id
... or ...
MAY contain zero or more [0..*] id
326 StructDocs Introduction Figure 1: Yes A-Q [observation: templateId
Constraits 2.16.840.1.113883.10.20.21.4.8(ope
format n)]
exchange
327 StructDocs Introduction 1.7.6 Null A-S
Flavor
328 StructDocs 1.7.2 Figure 6: A-S
Conformance nullFlavor
Statements explictly
disallowed
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329 StructDocs General Table 2: A-T
Header Basic
Template Confidenti
ality Kind
Value Set
330 StructDocs General Table 10: A-T
Header Personal
Template Relationshi
p Role
Type Value
Set
331 StructDocs General Table 12: A-T
Header Postal
Template Code
Value Set
332 StructDocs General Table 15: A-T
Header PostalAddr
Template essUse
Value Set
333 StructDocs General Table 16: A-T
Header EntityNam
Template eUse Value
Set
334 StructDocs General Table 16: A-T
Header EntityNam
Template eUse Value
Set
335 StructDocs General Table 16: A-T
Header EntityNam
Template eUse Value
Set
336 StructDocs Document- A-T
Level
Templates
337 StructDocs Document- Table 18: A-T
Level Document
Templates Types and
Required/O
ptional
Sections
338 StructDocs Document- 3.1.1.3 A-T
Level documenta
Templates tionOf/serv
iceEvent
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339 StructDocs Document- 3.1.1.3 A-Q
Level documenta
Templates tionOf/serv
iceEvent
340 StructDocs 3.2 Table 19: A-Q
Consultation Consultatio
Note n Note
LOINC
Document
Codes
341 StructDocs 3.3 3.3.1.6. A-T
Diagnostic documenta
Imaging tionOf
Report
342 StructDocs 3.3 3.3.1.7 Neg-Mi
Diagnostic authorizati
Imaging on
Report
343 StructDocs 3.6 Operative 3.6.1.4 A-T
Note documenta
tionOf
344 StructDocs 3.7 3.7.1.6 A-T
Procedure ServiceEve
Note nt
345 StructDocs 4 Section- A-T
Level
Templates
346 StructDocs 4 Section- Table 31: A-T
Level Sections
Templates and
Required/O
ptional
Document
Types
347 StructDocs 4 Section- 4.4 Neg-Mi
Level Assessmen
Templates t Section
51848-0
348 StructDocs 4 Section- 4.5 Neg-Mi
Level Assessmen
Templates t and Plan
Section
51487-2
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349 StructDocs 4 Section- 4.11 A-T
Level Discharge
Templates Diet
Section
10154-3
350 StructDocs 4 Section- 4.11 Neg-Mi
Level Discharge
Templates Diet
Section
10154-3
351 StructDocs 4 Section- 4.11 Neg-Mi
Level Discharge
Templates Diet
Section
10154-3
352 StructDocs 4 Section- 4.11 Neg-Mi
Level Discharge
Templates Diet
Section
10154-3
353 StructDocs 4 Section- 4.17 Neg-Mi
Level History of
Templates Past Illness
Section
11348-0
354 StructDocs 4 Section- 4.18 Neg-Mi
Level History of
Templates Present
Illness
Section
11348-0
355 StructDocs 4 Section- 4.18 Neg-Mi
Level History of
Templates Present
Illness
Section
11348-0
356 StructDocs 4 Section- 4.18 Neg-Mi
Level History of
Templates Present
Illness
Section
11348-0
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357 StructDocs 4 Section- 4.20 Neg-Mi
Level Hospital
Templates Discharge
Diagnosis
Section
48765-2
358 StructDocs 4 Section- 4.20 Neg-Mi
Level Hospital
Templates Discharge
Diagnosis
Section
48765-2
359 StructDocs 4 Section- 4.20 Neg-Mi
Level Hospital
Templates Discharge
Diagnosis
Section
48765-2
360 StructDocs 4 Section- 4.21 A-T
Level Hospital
Templates Discharge
Medication
s Section
10183-2
361 StructDocs 4 Section- 4.24 A-Q
Level Immunizati
Templates ons Section
11369-
362 StructDocs 4 Section- 4.28 A-Q
Level Medication
Templates s Section
10160-0
363 StructDocs 4 Section- 4.34 Neg-Mi
Level Physical
Templates Exam
Section
29545-1
364 StructDocs 4 Section- 4.34 Neg-Mi
Level Physical
Templates Exam
Section
29545-1
365 StructDocs 4 Section- 4.35 Pan A-Q
Level Section
Templates 18776-5
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366 StructDocs 4 Section- 4.40 A-T
Level Problem
Templates List
Section
11450-4
367 StructDocs 4 Section- 4.40 A-Q
Level Problem
Templates List
Section
11450-4
368 StructDocs 4 Section- 4.47 A-Q
Level Procedure
Templates Specimens
Taken
Section
369 StructDocs 4 Section- 4.48 A-Q
Level Procedures
Templates Section
47519-4
370 StructDocs 4 Section- 4.50 A-Q
Level Results
Templates Section
30954-2
371 StructDocs 4 Section- 4.56 Vital A-Q
Level Signs
Templates Section
8716-3
372 StructDocs 5 Entry- 5.10 Neg-Mi
Level Episode
Templates Observatio
n
373 StructDocs 5 Entry- 5.21 A-T
Level Procedure
Templates Activity
Act
374 StructDocs 5 Entry- 5.21 A-T
Level Procedure
Templates Activity
Act
375 StructDocs 5 Entry- 5.22 A-T
Level Procedure
Templates Activity
Observatio
n
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376 StructDocs 5 Entry- 5.23 A-T
Level Procedure
Templates Activity
Procedure
377 StructDocs Appendix B - Table 60: A-Q
Changes Section
from Template
Previous Change
Guides Tracking
378 StructDocs 3.9 Neg-Mi
Unstructured
Documents
379 StructDocs 3.9 A-Q
Unstructured
Documents
380 StructDocs 3.6.1.3 A-S
3.7.1.5
381 StructDocs overall A-C
382 StructDocs overall A-C
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383 StructDocs overall A-S
384 StructDocs overall A-Q
385 StructDocs ?? CDAR2_IG_C 1.1 / A-S
ONSOL_R1_ general
D1_2011APR comment
386 StructDocs CDAR2_IG_C 1.3 A-S All CDA templates required for Final
ONSOL_R1_ Rules for Meaningful Use are
D1_2011APR included in this guide.
387 StructDocs CDAR2_IG_C 1.4 A-S
ONSOL_R1_
D1_2011APR
388 StructDocs CDAR2_IG_C 1.4 A-T When complete, this guide will fully When complete, this guide will fully
ONSOL_R1_ specify a compliant CDA R2 specify a compliant CDA R2
D1_2011APR document for each of document document for each document type.
types.
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389 StructDocs CDAR2_IG_C 1.4 A-S These unconsolidated entries are
ONSOL_R1_ included here for reference, flagged
D1_2011APR as pre-review.
390 StructDocs CDAR2_IG_C 1.4 A-T A full mapping of change is A full mapping of change is
ONSOL_R1_ anticipated for after ballot. anticipated to occur after ballot.
D1_2011APR
391 StructDocs CDAR2_IG_C 1.6 A-S The value of this attribute provides a
ONSOL_R1_ unique identifier for the template in
D1_2011APR question.
392 StructDocs CDAR2_IG_C 1.7 A-S CDA implementers think about
ONSOL_R1_ conformance requirements in terms
D1_2011APR of three general levels corresponding
to three different, incremental types
of conformance statements
393 StructDocs CDAR2_IG_C 1.7.2 A-S Most conformance statements within Remove these statements, they're
ONSOL_R1_ this implementation guide are production notes and offer no
D1_2011APR presented as constraints from a guidance for implementation.
Template Database (Tdb). An
algorithm converts constraints
recorded in a Templates Database to
a printable presentation.
AND
Constraints from the Model-Driven
Health Tools (MDHT) look similar,
but do not contain the same unique
identifiers; many reference
conformance statements from the
source document.
394 StructDocs CDAR2_IG_C 1.7.2 A-S In open templates, all of the features
ONSOL_R1_ of the CDA R2 base specification
D1_2011APR are allowed except as constrained by
the templates.
395 StructDocs CDAR2_IG_C 1.7.5 A-S These controlled vocabularies are
ONSOL_R1_ defined in ...
D1_2011APR
396 StructDocs CDAR2_IG_C 1.7.5 A-S ….value-set identifiers …
ONSOL_R1_
D1_2011APR
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397 StructDocs CDAR2_IG_C 1.8.1 A-S
ONSOL_R1_
D1_2011APR
398 StructDocs CDAR2_IG_C Table 1 A-S DIR.xml… DIR.sample.XML
ONSOL_R1_
D1_2011APR
399 StructDocs CDAR2_IG_C 2 A-S
ONSOL_R1_
D1_2011APR
400 StructDocs ?? 1.7.3 Neg-Mi The keyword "SHALL" implies a The keyword "SHALL" allows
lower cardinality of 1, but allows NULL values.
NULL values.
401 ?? 1.7.6 A-S Any SHALL conformance statement
may use nullFlavor, unless the
attribute is explicity required or the
nullFlavor is explicitly disallowed.
402 ?? 2.1 A-S 7. SHALL contain exactly one [1..1]
effectiveTime (CONF:5256).
a. 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).
3. This patient SHALL contain
exactly one [1..1] birthTime
(CONF:5298).
a. SHALL be precise to year
(CONF:5299).
b. SHOULD be precise to day
(CONF:5300).
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403 ?? 2.1 Neg-Mj 7. This patient MAY contain zero or Remove the extended-namespace-
more [0..*] sdwg:raceCode, which based constraint.
SHALL be selected from ValueSet
2.16.840.1.113883.1.11.14914 Race
DYNAMIC (CONF:7263).
404 A-T
405 A-T
406 Neg-Mj
407 Neg-Mj
408 Neg-Mj
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409 Neg-Mi
410 A-S
411 A-T In section templates, the subheadings “With coded entries optional”,
“Optional Entries”, “Required “With coded entries required”
Entries”
412 Neg-Mj
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413 4.28 Neg-Mj
414 Neg-Mi
415 4.4 A-T
416 4.4 A-T
417 Neg-Mi
418 5.6 A-T
419 A-S
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420 A-S
421 A-T
422 A-S
423 5.29 Neg-Mi
424 Neg-Mi
425 CONF:175 A-T
426 CONF- A-S
7556
427 2.1.6 A-S The intended recipient MAY also be “If the intended recipient of the
the health chart of the patient, in document is the patient's health
which case the receivedOrganization chart, set the receivedOrganization
is the scoping organization of that to be the scoping organization for
chart. that chart.”
428 2.1.6, A-Q
3.3.1.4
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429 CONF:843 Neg-Mi If present, 1. If present, responsibleParty
9 responsibleParty/assignedEntity SHALL 1..1 contain assignedEntity,
SHALL have at least one which /// a. SHALL [1..2] contain
assignedPerson or assignedPerson and/or
representedOrganization element representedOrganization.
present.
430 A-S
431 A-S
432 3.7.1.2 / A-T This code/@code MAY contain
CONF:849 exactly one [1..1] code/@code, ...
8
433 3.7.1.2 / A-T 3. SHOULD contain exactly one
CONF:849 [1..1] code/@code="28570-0"
7-8498 Procedure Note (CodeSystem:
2.16.840.1.113883.6.1 LOINC)
(CONF:8497). a. This code/@code
MAY contain exactly one [1..1]
code/@code, which MAY be
selected from ValueSet
2.16.840.1.113883.11.20.6.1
ProcedureNoteDocumentTypeCodes
DYNAMIC (CONF:8498).
434 5.23 Neg-Mj template name: Procedure Activity
Procedure
435 A-S
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436 5.23 A-Q
437 CONF:765 A-T 5. SHALL contain exactly one [1..1]
7 code (CONF:7656). a. This code
@code in a procedure activity
SHOULD be selected from... (CONF-
7657)
438 StructDocs Neg-Mj
439 StructDocs Table 18 A-T Consultation Note row: Use asterisk and reference to how
Assessment/Assessment and Plan the Assessment and Plan sections
Plan/Assessment and Plan should be implmented. See table 31
for example.
440 StructDocs Table 2 A-T Confidentiality Code Confidentiality Code
441 StructDocs 4.35 A-T 2.16.840.1.113883.10.20.21.2.10 2.16.840.1.113883.10.20.22.2.10
442 StructDocs 2.3 1 (conf A-S 1. SHALL NOT have mixed Please add child comment statement
7278) content (CONF:7278). regarding what is meant by mixed
content such as "A mixed complex
type element contains any
combination of attributes, elements,
and text.3"
443 StructDocs 2.3 Table 17: Neg-Mi … which SHALL be selected from create new valueSet and adjust
EntityNam ValueSet applicable conformance statements
ePartQualif 2.16.840.1.113883.1.11.15888
ier Value EntityNamePartQualifier STATIC
Set 2005-05-01 (CONF:7156).
Everywhere this valueSet is used on
person name
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444 StructDocs 2.1 Table 11: A-T extra row in table(before Alabama remove
State Value row)
Set
445 StructDocs General A-T General comment: Need to develop
comment: discrete computable conformance
(Examples: statements for "or" requirements
3.1.1.4 and
3.2.1.3
446 StructDocs 3.2.1.3 Participant A-S c. When participant/@typeCode is
IND, associatedEntity/@classCode
SHALL be PRS,
NOK,CAREGIVER, AGNT,GUAR,
or ECON. (CONF:8380).
447 StructDocs 2.1.1 #9 A-S 9. This patient SHOULD contain 9. This patient MAY contain zero or
RecordTarge zero or one [0..1] guardian one [0..1] guardian (CONF:5325).
t (CONF:5325).
448 StructDocs 3.2.1.3 A-S
(USheader)
3.4.1.3
3.5.1.3
Participant)
449 StructDocs General A-S
comment
about header
template
450 StructDocs 5.3 Allergy A-T
Problem Act
451 StructDocs 5.6 Neg-Mi The value of negationInd should not
Condition normally be set to true. Instead, to
Entry record that there is "no prior history
[Observation of chicken pox" one would use a
: templateId coded value indicated exactly that.
2.16.840.1.1
13883.10.20.
22.4.4(open)
]
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452 StructDocs 5.6 A-T This section uses the …..
Condition
Entry
[Observation
: templateId
2.16.840.1.1
13883.10.20.
22.4.4(open)
]
453 StructDocs 4.40 Problem A-T link to condition entry doesn’t work
List Section
11450-4
454 StructDocs 5.5 Neg-Mi 1. SHALL contain exactly one [1..1]
Condition @classCode="ACT" Act
[Act: (CodeSystem:
templateId 2.16.840.1.113883.5.6
2.16.840.1.1 HL7ActClass) (CONF-146)
13883.10.20.
22.4.3(open)
]
455 StructDocs 4.48 A-T Therefore this section contains
Procedures procedure templates represented with
Section three RIM classes Act: Observation
47519-4 and Procedure
(Template
Description)
456 StructDocs General A-S
Comment
457 StructDocs 4.20 Hospital A-S The Discharge Diagnosis section
Discharge (entry) describes the relevant
Diagnosis problems or diagnoses that occurred
Section during the hospitalization or that
48765-2 need to be followed after
and hospitalization. This section includes
5.7 an optional entry to record patient
Discharge conditions
Diagnosis
Act
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458 StructDocs Table 58: A-S Hospital Admission Section no
Discharge longer defined (deemed unessesary
Summary during consol anlaysis) suggest
Cardinality adding entry similar to 5.7 Discharge
Updates Diagnosis Act defining Admission
Diagnosis
459 StructDocs 4.21 Hospital A-T link to Discharge Medication
Discharge template doesn’t work
Medications
Section
(optional
entries)
10183-2
460 StructDocs General A-T all the conformance statements 1. A reference/@value SHOULD
requirring a text reference should be point to its corresponding narrative
written in the same style (using the approach defined in CDA
Release 2, section 4.3.5.1 ).
461 StructDocs 4.50 Results Neg-Mi 5. SHALL contain at least one [1..*] 4. SHOULD contain at least one
Section entry (CONF:7112) such that it [1..*] entry (CONF:7119) such that
30954-2 a. SHALL contain exactly one [1..1] it
Required Result Organizer a. SHALL contain exactly one [1..1]
Entries (templateId:2.16.840.1.113883.10.2 Result Organizer
[component: 0.22.4.1) (CONF:7113 (templateId:2.16.840.1.113883.10.2
templateId 0.22.4.1)
2.16.840.1.1 5. SHALL contain exactly one [1..1]
13883.10.20. Result Observation
21.2.3.1 (templateId:2.16.840.1.113883.10.2
0.22.4.2)
462 StructDocs 5.26 Result A-T
Organizer
.
463 StructDocs 5.26 Result A-T a. SHOULD be "BATTERY" or 1.This organizer SHOULD contain
Organizer "CLUSTER" exactly one [1..1]
conf 1a @classCode="CLUSTER"
CONF:7165 CLUSTER (CodeSystem:
2.16.840.1.113883.5.6
HL7ActClass)
OR
1. SHOULD contain exactly one
[1..1] @classCode="BATTERY"
BATTERY (CodeSystem:
2.16.840.1.113883.5.6
HL7ActClass)
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464 StructDocs 5.26 Result A-T a. SHOULD be from LOINC a. This code @code in a result
Organizer (CodeSystem: organizer SHOULD be selected
conf 5a 2.16.840.1.113883.6.1) or from LOINC (codeSystem
(CONF:7164 SNOMED CT (CodeSystem: 2.16.840.1.113883.6.1) or
). 2.16.840.1.113883.6.96), and MAY SNOMED-CT CT (codeSystem
be selected from CPT-4 2.16.840.1.113883.6.96), and MAY
(CodeSystem: be selected from CPT-4
2.16.840.1.113883.6.12) (codeSystem
(CONF:7164). 2.16.840.1.113883.6.12)
465 StructDocs 5.3 Allergy 8b A-T link to allergy/alert Observation
Problem Act doesn't work
466 StructDocs general Neg-Mi " SHOULD ... one [1..1] "
467 StructDocs Table 52 multiple A-S SHALL use: Value Set: HL7 SHALL use VALUE SET:
conf ServiceDeliveryLocationRoleType HealthcareServiceLocation
statenment 2.16.840.1.113883.1.11.17660 (2.16.840.1.113883.1.11.20275)
s Code System(s): HL7 RoleCode
(2.16.840.1.113883.5.111
468 StructDocs 2.1.1 11b A-S b. Such languageCommunications, if add: Such
RecordTarge present, MAY contain zero or one languageCommunications, if
t [0..1] modeCode, which SHALL be present, SHOULD contain zero or
selected from ValueSet one [0..1] proficiencyLevelCode
2.16.840.1.113883.1.11.12249 which SHALL be selected from
(member examples: EWR Language valueSet
Ability Mode Expressed written, LanguageAbilityProficiency
RSP Language Ability Mode (2.16.840.1.113883.1.11.12199)
Received spoken )
469 StructDocs 4.40 Problem A-T links
List Section
5.5
Condition
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470 StructDocs 5.6 Neg-Mi
Condition a. The <effectiveTime> of this
Entry <observation> is the time interval
7. SHOULD over which the <observation> is
contain known to be true. The <low> and
exactly one <high> values should be no more
[1..1] precise than known, but as precise as
effectiveTim possible. While CDA allows for
e (CONF- multiple mechanisms to record this
CONSOL- time interval (e.g., by low and high
532) values, low and width, high and
width, or center point and width), we
are constraining Medical summaries
to use only the low/high form. The
<low> value is the earliest point for
which the condition is known to
have existed. The <high> value,
when present, indicates the time at
which the observation was no longer
known to be true. Thus, the
implication is made that if the
<high> value is specified, that the
observation was no longer seen after
this time, and it thus represents the
date of resolution of the problem.
Similarly, the <low> value may seem
to represent onset of the problem.
Neither of these statements is
necessarily precise, as the <low> and
<high> values may represent only an
approximation of the true onset and
471 StructDocs 5.6 resolution (respectively) times. For
C83 references
Condition
Entry
472 StructDocs 5.6 8. SHALL contain exactly one [1..1] SHALL contain exactly one [1..1]
Condition value, which SHALL be selected value with @xsi:type="CD", where
Entry from ValueSet the @code SHALL be selected from
2.16.840.1.113883.3.88.12.3221.7.4 ValueSet
Problem DYNAMIC 2.16.840.1.113883.3.88.12.3221.7.4
Problem DYNAMIC (CONF:7335).
473 StructDocs 5.6 This section uses the linking,
Condition severity, clinical status and comment
Entry content specifications defined
elsewhere in the technical
framework.
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474 StructDocs 5.6 The value of negationInd should not Remove
Condition normally be set to true. Instead, to
Entry record that there is "no prior history
of chicken pox", one would use a
coded value indicated exactly that.
However, it is not always possible to
record problems in this manner,
especially if using a controlled
vocabulary that does not supply pre-
coordinated negations , or which do
not allow the negation to be recorded
with post-coordinated coded
terminology.
475 StructDocs 5.6
Condition
Entry
476 StructDocs 2 A-S General Header Template Use of the CDA Header
477 StructDocs 2 A-S
478 StructDocs A-Q
479 StructDocs A-T Table 18: H&P Vital Sign section is
in both Required and optional
columns
480 StructDocs Neg-Mi Vital Signs Organizer 2.16.840.1.113883.10.20.22.4.26
[organizer: templateId
2.16.840.1.113883.10.20.21.4.26(op
en)]
481 StructDocs A-S
482 StructDocs A-S
483 StructDocs A-Q
484 StructDocs A-T
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485 StructDocs A-T
486 StructDocs 1 1.3 Scope Neg-Mi At present, the entry-level templates These entry-level templates are
cover only those required for intended to only satisfy the
Meaningful Use. requirements for MU Stage 1.
487 1 1.2 Neg-Mi This ballot package represents a
Purpose partial harmonization of these works
and includes all required CDA
templates in Final Rules for
Meaningful Use
488 1 1.2 Neg-Mj When complete, this guide will
Purpose provide a single source for
implementing the following CDA
documents
489 3 Table 18 Neg-Mi Post Operative Diagnosis Postoperative Diagnosis
490 3 Table 18 Neg-Mi Post Procedure Diagnosis Postprocedure Diagnosis
491 StructDocs General
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492 StructDocs General Appendix Yes Neg-Mj
B
493 StructDocs 1.4 A-T … an open source application first ...an open source application first
Approach developed for the Centers for developed for the Centers for
Disease and Prevention and in active Disease Control and Prevention and
use… in active use...
494 StructDocs General 1.7.1 Neg-Mi
Levels of
Constraint
495 StructDocs 1.7.2 A-Q
Conformance
Statements
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496 StructDocs General 1.7.2
Conforman
ce
Statements
497 StructDocs General 1.7.2 Neg-Mi e.x. 8. SHALL contain exactly one e.x. 8. SHALL contain exactly one
Conforman [1..1] confidentialityCode, which [1..1] confidentialityCode
ce SHOULD be selected from ValueSet (CONF:XXXX).
Statements 2.16.840.1.113883.1.11.16926 a. confidentialityCode/@code
BasicConfidentialityKind STATIC SHOULD be selected from ValueSet
2010-04-21 (CONF:5259). 2.16.840.1.113883.1.11.16926
BasicConfidentialityKind STATIC
2010-04-21 (CONF:5259).
498 StructDocs 1.7.2 A-S In open templates, all of the features
Conformance of the CDA R2 base specification
Statements are allowed except as constrained by
the templates. By contrast, a closed
template specifies everything that is
allowed and nothing further may be
included.
499 StructDocs General 1.7.2 Neg-Mj
Conforman
ce
Statements
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500 StructDocs General 1.7.2 Neg-Mj
Conforman
ce
Statements
501 StructDocs General 1.7.2 Neg-Mj
Conforman
ce
Statements
502 StructDocs General Neg-Mi
503 StructDocs General 1.7.5 Neg-Mj
Vocabulary
Conforman
ce
504 StructDocs General Neg-Mi 1. This 1. This
representedCustodianOrganization representedCustodianOrganization
SHALL contain exactly one [1..1] id SHALL contain one or more [1..*]
(CONF:5522). id (CONF:5522).
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505 StructDocs 1.7.5 Neg-Mj
Vocabulary
Conformance
506 StructDocs 1.8.3 Non- Neg-Mj
Consolidated
Entries
507 StructDocs 1.9 Content Neg-Mj
of the
Package
508 StructDocs 2.1 US 1 Neg-Mj 1. SHALL contain exactly one [1..1] 2. SHALL contain exactly one [1..1]
Realm realmCode="US" (CONF:5249). realmCode (CONF:5249).
Clinical a. This realmCode SHALL contain
Document exactly one [1..1] @code="US"
Header (CONF:XXXX).
509 StructDocs 2.1 US 3 Neg-Mi 3. SHALL contain exactly one [1..1] SHALL contain exactly one [1..1]
Realm templateId/@root="2.16.840.1.1138 templateId (CONF:XXXX) such
Clinical 83.10.20.22.1.1" (CONF:5252). that it
Document a. SHALL contain exactly one
Header [1..1]
@root="2.16.840.1.113883.10.20.2
2.1.1" (CONF:5252).
510 StructDocs 2.1 US 6 A-S 6. SHALL contain exactly one [1..1] 6. SHALL contain exactly one [1..1]
Realm title (CONF:5254). title (CONF:5254).
Clinical a. can either be a locally defined a. MAY contain a locally defined
Document name or the display name name or the display name
Header corresponding to corresponding to
clinicalDocument/code clinicalDocument/code
(CONF:5255). (CONF:5255).
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511 StructDocs 2.1 US 7 A-S 7. SHALL contain exactly one [1..1] 7. SHALL contain exactly one [1..1]
Realm effectiveTime (CONF:5256). effectiveTime (CONF:5256).
Clinical a. The value of @value, if present, a. The value of @value, if present,
Document SHALL be precise to the day and SHALL be precise to the day
Header SHOULD be precise to the minute. (CONF:XXXX)
If precise to minute, SHOULD b. The value of @value, if present,
include time-zone offset SHOULD be precise to the minute
(CONF:5257). (CONF:XXXX).
ii. If precise to minute, SHOULD
include time-zone offset
(CONF:5257).
512 StructDocs 2.1 US 8 Neg-Mi 8. SHALL contain exactly one [1..1] 8. SHALL contain exactly one [1..1]
Realm confidentialityCode, which confidentialityCode
Clinical SHOULD be selected from ValueSet (CONF:XXXX).
Document 2.16.840.1.113883.1.11.16926 a. confidentialityCode/@code
Header BasicConfidentialityKind STATIC SHOULD be selected from ValueSet
2010-04-21 (CONF:5259). 2.16.840.1.113883.1.11.16926
BasicConfidentialityKind STATIC
2010-04-21 (CONF:5259).
513 StructDocs 2.1 US 9 Neg-Mi 9. SHALL contain exactly one [1..1] 9. SHALL contain exactly one [1..1]
Realm languageCode/@code, which languageCode (CONF:XXXX).
Clinical SHALL be selected from ValueSet a. languageCode/@code SHALL be
Document 2.16.840.1.113883.1.11.11526 selected from ValueSet
Header LanguageValueSet DYNAMIC 2.16.840.1.113883.1.11.11526
(CONF:5372). LanguageValueSet DYNAMIC
(CONF:5372).
514 StructDocs 2.1 US 9 A-Q 9. SHALL contain exactly one [1..1]
Realm languageCode/@code, which
Clinical SHALL be selected from ValueSet
Document 2.16.840.1.113883.1.11.11526
Header LanguageValueSet DYNAMIC
(CONF:5372).
515 StructDocs 2.1.1 12.a A-S i. Such patientRoles SHALL contain i. Each patientRole SHALL contain
RecordTarge at least one [1..*] id (CONF:5268). at least one [1..*] id (CONF:5268).
t
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516 StructDocs 2.1.1 12.a A-S ii. Such patientRoles SHALL ii. Each patientRole SHALL contain
RecordTarge contain at least one [1..*] US Realm at least one [1..*] US Realm Clinical
t Clinical Document Header Address Document Header Address
(templateId:2.16.840.1.113883.10.2 (templateId:2.16.840.1.113883.10.2
0.22.5.2) (CONF:5271). 0.22.5.2) (CONF:5271).
517 StructDocs 2.1.1 12.a.iii A-S 1. Such telecoms SHOULD contain 1. Each telecom SHOULD contain
RecordTarge @use, which SHOULD be selected @use (CONF:XXXX)
t from ValueSet a telecom/@use SHOULD be
2.16.840.1.113883.11.20.9.20 selected from ValueSet
Telecom use (US Realm Clinical 2.16.840.1.113883.11.20.9.20
Document Header) DYNAMIC Telecom use (US Realm Clinical
(CONF:5375). Document Header) DYNAMIC
(CONF:5375).
518 StructDocs 2.1.1 12.a A-S iv. Such patientRoles SHALL iv. Each patientRole SHALL contain
RecordTarge contain exactly one [1..1] patient exactly one [1..1] patient
t (CONF:5283). (CONF:5283).
519 StructDocs 2.1.1 12.a.iv Neg-Mi 2. This patient SHALL contain 2. patient SHALL contain exactly
RecordTarge exactly one [1..1] one [1..1]
t administrativeGenderCode/@code, administrativeGenderCode
which SHALL be selected from (CONF:XXXX)
ValueSet 2.16.840.1.113883.1.11.1 a.
Administrative Gender (HL7 V3) administrativeGenderCode/@code
DYNAMIC (CONF:6394). SHALL be selected from ValueSet
2.16.840.1.113883.1.11.1
Administrative Gender (HL7 V3)
DYNAMIC (CONF:6394).
520 StructDocs 2.1.1 12.a.iv Neg-Mi 4. This patient SHOULD contain 4. patient SHOULD contain zero or
RecordTarge zero or one [0..1] one [0..1] maritalStatusCode
t maritalStatusCode/@code, which (CONF:XXXX)
SHOULD be selected from ValueSet a. maritalStatusCode/@code
2.16.840.1.113883.1.11.12212 SHOULD be selected from ValueSet
MaritalStatus DYNAMIC 2.16.840.1.113883.1.11.12212
(CONF:5303). MaritalStatus DYNAMIC
(CONF:5303).
521 StructDocs 2.1.1 12.a.iv Neg-Mi 7. This patient MAY contain zero or
RecordTarge more [0..*] sdwg:raceCode, which
t SHALL be selected from ValueSet
2.16.840.1.113883.1.11.14914 Race
DYNAMIC (CONF:7263).
522 StructDocs 2.1.1 12.a.iv Neg-Mi 9. This patient SHOULD contain
RecordTarge zero or one [0..1] guardian
t (CONF:5325).
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523 StructDocs 2.1.1 12.a.iv.9 Neg-Mi c. This guardian, if present, SHALL c. This guardian, MAY contain zero
RecordTarge contain exactly one [1..1] telecom or more [1..1] telecom
t (CONF:5382). (CONF:5382).
524 StructDocs 2.1.1 A-S d. This guardian, if present, SHALL d. This guardian, if present, SHALL
RecordTarge contain exactly one [1..1] contain exactly one [1..1]
t guardianPerson (CONF:5385). guardianPerson (CONF:5385).
525 StructDocs 2.1.1 12.a.v Neg-Mi 1. This providerOrganization, if 1. This providerOrganization, if
RecordTarge present, SHALL contain exactly one present, SHALL contain one or
t [1..1] id (CONF:5417). more [1..*] id (CONF:5417).
526 StructDocs 2.1.2 Author 13 Neg-Mi i. SHALL be precise to the day and a. Such authors SHALL contain
SHOULD be precise to the minute exactly one [1..1] time
(CONF:5446). (CONF:5445).
i. SHALL be precise to the day
(CONF:5446)
ii. SHOULD be precise to the
minute (CONF:XXXX).
527 StructDocs 2.1.2 Author 13.b Neg-Mi i. This assignedAuthor SHALL i. This assignedAuthor SHALL
contain exactly one [1..1] id contain one or more [1..*] id
(CONF:5449). (CONF:5449).
528 StructDocs 2.1.3 14.a Neg-Mi i. This assignedEntity SHALL i. This assignedEntity SHALL
dataEnterer contain exactly one [1..1] id contain one or more [1..*] id
(CONF:5443). (CONF:5443).
529 StructDocs 2.1.5 16.a.i Neg-Mi 1. This 1. This
Custodian representedCustodianOrganization representedCustodianOrganization
SHALL contain exactly one [1..1] id SHALL contain one or more [1..*]
(CONF:5522). id (CONF:5522).
530 StructDocs 2.1.7 18 A-S a. This legalAuthenticator, if present, a. This legalAuthenticator, if
legalAuthenti SHALL contain exactly one [1..1] present, SHALL contain exactly one
cator time (CONF:5580). [1..1] time (CONF:5580).
i. SHALL be precise to the day and i. SHALL be precise to the day
SHOULD be precise to the minute. (CONF:XXXX)
If precise to minute, SHOULD ii. SHOULD be precise to the
include time-zone offset minute. (CONF:XXXX)
(CONF:5581). a. If precise to minute, SHOULD
include time-zone offset
(CONF:5581).
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531 StructDocs 2.1.8 19 A-S a. Such authenticators, if present, a. Each authenticator SHALL
Authenticato SHALL contain exactly one [1..1] contain exactly one [1..1] time
r time (CONF:5608). (CONF:5608).
i. SHALL be precise to the day and i. SHALL be precise to the day
SHOULD be precise to the minute. (CONF:XXXX)
If precise to minute, SHOULD ii. SHOULD be precise to the
include time-zone offset minute. (CONF:XXXX)
(CONF:5634). a. If precise to minute, SHOULD
include time-zone offset
(CONF:5634).
532 StructDocs 2.2 US 6 Neg-Mj 6. SHALL contain exactly one [1..1]
Realm postalCode, which SHALL be
Clinical selected from ValueSet
Document 2.16.840.1.113883.3.88.12.80.2
Header PostalCodeValueSet DYNAMIC
Address (CONF:7294).
533 StructDocs 2.2 US 7 Neg-Mj 7. SHOULD contain zero or one
Realm [0..1] country, which SHALL be
Clinical selected from ValueSet
Document 2.16.840.1.113883.3.88.12.80.63
Header CountryValueSet DYNAMIC
Address (CONF:7295).
534 StructDocs 2.2 US Neg-Mi [addr: templateId
Realm 2.16.840.1.113883.10.20.21.5.2(ope
Clinical n)]
Document
Header
Address
535 StructDocs 2.3 US Neg-Mi [name: templateId
Realm 2.16.840.1.113883.10.20.21.5.1(ope
Clinical n)]
Document
Header
Name
536 StructDocs 2.3 US 4 A-S a. Second given is middle name a. the second occurrence of given
Realm (CONF:7163). (given[2]) if provided, SHALL
Clinical include middle name or middle
Document initial (CONF:7163).
Header
Name
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537 StructDocs 2.4 3 A-S a. The serviceEvent/effectiveTime a. serviceEvent/effectiveTime
serviceEvent element SHOULD be present with SHOULD contain exactly one [0..1]
in a CDA effectiveTime/low element and low (CONF:XXXX).
Header SHALL include effectiveTime/high i. effectiveTime/low SHALL be
element if a width element is not accurate to the day (CONF:XXXX)
present. The ii. effectiveTime/low MAY be
serviceEvent/effectiveTime element accurate to the second.
SHALL be accurate to the day, and (CONF:7602).
MAY be accurate to the second. b. If a width element is not present,
(CONF:7602). the serviceEvent/effectiveTime
SHALL include exactly one [1..1]
high.
i. effectiveTime/high SHALL be
accurate to the day (CONF:XXXX)
ii. effectiveTime/high MAY be
accurate to the second.
(CONF:7602).
c. serviceEvent/effectiveTime
SHALL be accurate to the day
(CONF:XXXX)
d. serviceEvent/effectiveTime MAY
be accurate to the second.
(CONF:7602).
538 StructDocs 3 Neg-Mj
DOCUMEN
T-LEVEL
TEMPLATE
S
539 StructDocs 3 Neg-Mi
DOCUMEN
T-LEVEL
TEMPLATE
S
540 StructDocs 3.1 Neg-Mi 3.1 Continuity of Care Document 3.1 Continuity of Care Document
Continuity of (CCD)/C32 (CCD)/C32
Care
Document
(CCD)/C32
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541 StructDocs 3.1.1 Header Neg-Mj 1. Conforms to US Realm Clinical 1. SHALL contain exactly one [1..1]
Constraints Document Header Template templateId (CONF:XXXX) such
Specific to (templateId: that it
CCD 2.16.840.1.113883.10.20.22.1.1). a. SHALL contain exactly one
[1..1]
@root="2.16.840.1.113883.10.20.2
2.1.1" (CONF:XXXX).
542 StructDocs 3.1.1.2 3. SHALL contain exactly one [1..1] 3. SHALL contain exactly one [1..1]
ClinicalDocu code/@code="34133-9" code (CONF:XXXX)
ment/code Summarization of Episode Note a. SHALL xontain exactly one
(CodeSystem: [1..1] @code="34133-9"
2.16.840.1.113883.6.1 LOINC) Summarization of Episode Note
(CONF:8451). (CodeSystem:
2.16.840.1.113883.6.1 LOINC)
(CONF:8451).
543 StructDocs 3.1.1.3 4.a.iii.b A-S i. The code MAY be the National i. code/@code MAY be selected
documentati Uniform Claims Committee Provider from 2.16.840.1.113883.6.101
onOf/service Taxonomy Code. (CONF:8462). National Uniform Claims
Event Committee Provider Taxonomy
Code DYNAMIC (CONF:8462).
544 StructDocs 3.1.1.4 A-S 1. CCD SHALL contain one or more 1. SHALL contain at least one [1..*]
Author ClinicalDocument / author / ClinicalDocument/ author
assignedAuthor / assignedPerson (CONF:XXXX)
and/or ClinicalDocument / author / a. Each author shall contain exactly
assignedAuthor / one [1..1] assignedAuthor
representedOrganization. (CONF:XXXX)
(CONF:8456). i. the assignedAuthor SHALL
contain at least one [1..*]
assignedPerson or at least one [1..*]
representedOrganization
(CONF:XXXX)
545 StructDocs 3.2.1 Neg-Mj 1. Conforms to US Realm Clinical 1. SHALL contain exactly one [1..1]
Consultation Document Header Template templateId (CONF:XXXX) such
Note Header (templateId: that it
Constraints 2.16.840.1.113883.10.20.22.1.1). a. SHALL contain exactly one
[1..1]
@root="2.16.840.1.113883.10.20.2
2.1.1" (CONF:XXXX).
546 StructDocs 3.2.1.3 A-S a. A participant element, if present, a. SHALL contain exactly one [1..1]
Participant SHALL contain an associatedEntity associatedEntity (CONF:XXXX)
element which SHALL contain i. This associatedEntity SHALL
either an associatedPerson or contain SHALL contain at least one
scopingOrganization element. [1..*] associatedPersonor at least
(CONF:8378). one [1..*] scopingOrganization
(CONF:XXXX)
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547 StructDocs 3.2.1.3 4 A-S b. A special class of participant is b. A special class of participant is
Participant the supporting person or the supporting person or
organization: an individual or an organization: an individual or an
organization that has a relationship organization that has a relationship
to the patient, including including to the patient, including including
parents, relatives, caregivers, parents, relatives, caregivers,
insurance policyholders, and insurance policyholders, and
guarantors. In the case of a guarantors. In the case of a
supporting person who is also an supporting person who is also an
emergency contact or next-of-kin, a emergency contact or next-of-kin,
participant element should be there SHOULD be exactly one [0..1]
present for each role recorded. participant for each role recorded.
(CONF:8379). (CONF:8379).
548 StructDocs 3.2.1.3 4 A-S d. When d. When
Participant associatedEntity/@classCode is associatedEntity/@classCode is
PRS, NOK, or ECON, then "PRS", "NOK", or "ECON", then
associatedEntity/code SHALL be associatedEntity SHALL contain
present having a value drawn from exactly one code (CONF:XXX).
the PersonalRelationshipRoleType i. code SHALL contain exactly one
domain or from SNOMED, any [1..1] @code selected from
subtype of "Person in the family" PersonalRelationshipRoleType
(303071001) DYNAMIC. domain or from SNOMED, any
(CONF:8381). subtype of "Person in the family"
(303071001) DYNAMIC.
(CONF:8381).
549 StructDocs 3.2.1.4 5 Neg-Mi a. The inFulfillmentOf element
inFullFillmen records the prior orders that are
tOf fulfilled (in whole or part) by the
service events described in this
document. For example, the prior
order might be an order for a
Consult, and this Consultation Note
would be in fulfillment of that order.
(CONF:8383).
550 StructDocs 3.2.1.4 5 Neg-Mi b. This inFulfillmentOf SHOULD b. This inFulfillmentOf SHALL
inFullFillmen contain exactly one [1..1] conatin exactly one [1..1] order
tOf order/id/@root (CONF:8385). (CONF:XXXX)
i. SHOULD contain exactly one
[1..1] id (CONF:8385).
551 StructDocs 3.2.1.5 A-S The authorization elements may be 6. MAY contain zero or more [0..*]
present. The Consultation Note authorization {CONF:XXXX)
provides no guidance on the
encoding of authorization elements.
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552 StructDocs 4 SECTION- Neg-Mi
LEVEL
TEMPLATE
S
553 StructDocs 4.1 Advance A-S 6. MAY contain exactly one [1..1]
Directives entry (CONF:7957).
Section
42348-3
554 StructDocs 4.24 Neg-Mi 5. SHOULD contain exactly one 5. SHOULD contain one or more
Immunizatio [1..1] entry (CONF:7969). [1..*] entry (CONF:7969).
ns Section
11369-6
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Committee Resolution
In person
resolution Comment Disposition
Comments requested grouping Disposition Withdrawn Committee Disposition Comment
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
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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.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 94 March 2003
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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.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 95 March 2003
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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)
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 96 March 2003
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"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.
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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.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 98 March 2003
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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")
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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.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 100 March 2003
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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.
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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?
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 102 March 2003
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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
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 103 March 2003
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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.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 104 March 2003
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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.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 105 March 2003
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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 Yes
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?
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 106 March 2003
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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 Yes
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 No
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?
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 107 March 2003
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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)
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 108 March 2003
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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,
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 109 March 2003
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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
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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,
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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
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Since this is a US Realm specification, recommend Yes
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 Yes
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.
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Since this is a US Realm specification, clarify that Yes
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.
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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 No
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 No
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 No
template and should require conformance to that
template and NOT duplicate all inherited
conformance rules.
Vital Sign Observation is based on Result template No
and should require conformance to that template and
NOT duplicate all inherited conformance rules.
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Sections that have two templates With and Without No
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 No
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 No
Directives, not Family History.
The Conformance statement example is for History No
of Past Illness, not History of Present Illness.
Are the Implants (4.25) and Procedure Implants No
(4.45) both required? How are they different?
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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.
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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.
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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.
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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?
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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.
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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.
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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
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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.
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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
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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.
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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 Yes Change Log
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
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Volume of Substantive Change, and lack of Yes Substantive
migration strategy between existing implementations Change
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
solutions. rules in the “Conformance Statements”
N-m: The Yes Conformance
section are not applied uniformly throughout the
guide.
N-M: The use of (open) and (closed) and the Yes Conformance
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, Yes Conformance
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.
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A-S: The repetition of “open” and/or “closed” for Yes Conformance
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 Yes Conformance
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.
Yes Conformance
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 Yes Conformance
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.
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N-m: Constraints should been rephrased so that it Yes Conformance
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 Yes Conformance
@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 Yes Conformance
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 Yes Failure to
Workgroup outlined a set of requirements. This Meet
guide failed to meet many of these requirements Requirements
which we feel are essential to support
implementation.
N-m: 6. The guide will use readily understandable Yes Failure to
terms and methods, or when domain specific terms Meet
or methods are used, will explain the domain Requirements
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 Yes Failure to
collapse the numerous CDA IGs upon which C32 Meet
and other clinical content specifications are based, Requirements
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.
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N-M: 9. "Schema" validation criteria will identify Yes Failure to
invalid document exchanges without requiring any Meet
specific knowledge of inputs. A document that is not Requirements
"schema" valid is not a communication conforming
to the implementation guide.
No validation criteria was delivered.
N-M: 10. Automated solutions will be used to Yes Failure to
generate the multiple representations, to ensure Meet
consistency of information in the guide Requirements
An automated solution was used to generate ONE
representation, rather than the multiple
representations desired.
N-M: 11. Auxiliary materials, including A) sample Yes Failure to
files, conformance data, Schematron, B) schema, Meet
UML models, et cetera, must be supplied with all Requirements
delivery formats to further support implementation.
No conformance data, schema or UML models were
provided to support implementation.
N-M: 12. Auxiliary materials will be supplied in Yes Failure to
standards based formats to support use with off-the- Meet
shelf tools. For example, XSD, Schematron, or XMI Requirements
files.
No XDS, Schematron or XMI files were provided.
N-M: 13. Tabular data will be made available in Yes Failure to
either CSV or XML formats to enable easy import Meet
into off-the-shelf products. Requirements
No tabular data was provided.
N-M: 15. Conformance rules will provide an Yes Failure to
explanation of the purpose of the requirement to Meet
help implementers understand what the rules are Requirements
trying to accomplish.
There were no explanations of requirements behind
conformance rules. The only explanatory text was
on templates.
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N-m: 16. Conformance rules must provide Yes Failure to
examples of conforming results, and should provide Meet
examples of non-conforming content when that will Requirements
aid implementation.
Conforming examples were not provided inline with
templates, but only as separately accessible files.
N-M: 17. The guide will provide necessary Yes Failure to
information in multiple views to enable access via a Meet
broad variety of learning styles, as well as examples Requirements
of conforming content
• Tree views
• Tabular views
• Graphical views
• Summary views
• UML models of conforming content
• Conformance statements in English prose
There are two views of the data, a narrative
summary of the template, and the set of
conformance statements. No tree views, tabular
views of the conformance rules, graphical views or
UML models of conforming content (with one
exception) were produced. The English prose still
needs work as there are distractions contained within
it that can be simplified.
N-M: Each template must have a constraint that Yes Contraints
indicates the class of item to which it applies.
e.g., template 2.16.840.1.113883.10.20.22.2.21 can
only be applied to a cda:section element. It is
invalid to try to assert it on a cda:ClinicalDocument
or cda:entry element.
N-m: Constraints on section code are clear, but Yes Clarity
confusing (and similar coded entries)
The cda:section shall contain only one [1..1] code
element.
cda:code/@code shall contain the value ‘Code’
meaning ‘Display Name’
cda:code/@codeSystem shall contain the value
‘codeSystemOID’ meaning ‘LOINC’.
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N-M: As specified, this template cannot be asserted Yes Datatype
within the clinical document because <templateId> flavor vs.
is not valid on <addr> elements. It most closely Template
represents the notion of a “data type” flavor in the
HL7 Release 2 data types. In order to detect
conformance to this constraint, a system must
examine each address appearing in the relevant
participation, determine if it meets the requirements
specified, and if it fails, move on to the next.
N-m: The ORIGINAL general header requirements Yes Datatype
were that each of the participants must have an flavor vs.
address. Was the intent here was that EACH <addr> Template
element conform to the US Realm Clinical
Document Header Address template, and if not,
why?
N-M: As specified, this template cannot be asserted Yes Datatype
within the clinical document because <templateId> flavor vs.
is not valid on <name> elements. It most closely Template
represents the notion of a “data type” flavor in the
HL7 Release 2 data types. In order to detect
conformance to this constraint, a system must
examine each name appearing in the relevant
participation, determine if it meets the requirements
specified, and if it fails, move on to the next.
N-m: The ORIGINAL general header requirements Yes Datatype
were that each of the participants must have a name. flavor vs.
Was the intent here is that EACH <name> element Template
conforms to the US Realm Clinical Document
Header Name template, and if not, why?
Advance Directives Section Yes Advance
[2.16.840.1.113883.10.20.22.2.21] Directives
N-M: The CDA Consolidation guide allows for only Section
one external reference to an advance directive
document, yet a patient may have more than one
document: A healthcare proxy, living will, power of
attorney and DNR could all exist, and each as a
separate document.
A-T: Change constraint 1 as follows: SHALL Yes Allergies and
contain exactly one [1..1] Adverse
code/@code/@code="48765-2" Allergies, adverse Reaction
reactions, alerts (CodeSystem: Section
2.16.840.1.113883.6.1 LOINC) (CONF:7528).
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N-M: TemplateId 2.16.840.1.113883.10.20.21.2.6.1 Yes Allergies and
changes the SHOULD requirement on the value for Adverse
the title of the section to a SHALL. Reaction
The title shall be required, the value constraint Section
should not be different from that of
2.16.840.1.113883.10.20.21.2.6
A-S: The Constraint: Yes Allergies and
SHALL contain at least one [1..*] entry Adverse
(CONF:7531) such that it SHALL contain exactly Reaction
one [1..1] Allergy Problem Act Section
(templateId:2.16.840.1.113883.10.20.22.4.30)
(CONF:7532).
Can be restated more simply as:
SHALL contain at least one [1..*]
entry/act[templateId/@root =
'2.16.840.1.113883.10.20.22.4.30'] (CONF:7532).
N-m: CCD, IHE and HITSP do not require DIRECT Yes Allergies and
containment of the act within the section. The act Adverse
could have been contained within a subsection. This Reaction
represents a change in the CDA Consolidation guide Section
that is not backwards compatible with prior work.
SHOULD on effectiveTime Yes Allergy
N-M: CDA Consolidation says an Allergy Observation
Observation should contain effectiveTime.
IHE requires effectiveTime with a low=’UNK’ when
start time is unknown. And allows high to be present
or absent. Relaxing this constraint to using ‘should’
creates unnecessarily incompatibility between the
CDA Consolidation guide and current
specifications, as the two support all of the same use
cases. The CCD, IHE and HITSP constraints on this
were CONSISTENT, and thus we also believe that
this change goes beyond the scope of work stated for
this guide.
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SHALL on Problem Status Yes Allergy
N-M: CDA Consolidation says that problem status is Observation
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
constrain, this represents a change that goes beyond
the scope of work stated for the guide.
The “Problem Status” entry in CCD is problematic
in many ways and subject to several comments later,
which is why this was OPTIONAL instead of
required.
Upon seeing requirement of Problem Status on the
Allergy Observation one would also expect it to be
required on the Problem Observation, but it does not
appear there.
N-M: Problem status uses a value set that contains Yes Problem
overlapping concepts, across multiple axes. A Status
problem can be intermittent, recurrent, and presently
active or inactive. The inclusion of “Rule Out” (a
possible diagnosis) and “Ruled Out” (negated) in
this value set has the potential to introduce errors in
implementation and interpretation of content.
Ruled out can only be used in a problem or allergy
observation that itself has been negated.
Suggested Resolution: Use the HITSP Problem
Status Value Set 2.16.840.1.113883.3.88.12.80.68
N-M: The allergy problem act maps to the Problem Yes Allergy
Act in CCD, and the Allergy Concern in IHE. The Problem Act
mapping table is incorrect its mapping to “Nothing”.
Code Yes Allergy
N-M: Code in the Allergy Problem Act is fixed to Problem Act
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.
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Condition Yes Condition
N-M: 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.
Value Yes Condition
A-T: SHALL contain exactly one [1..1] value, which
SHALL be selected from ValueSet
2.16.840.1.113883.3.88.12.3221.7.24 Problem
DYNAMIC (CONF-CONSOL-533)
Condition Entry Yes Condition
N-m: The name Condition Entry and Problem
Observation are used to refer to this template in
different places in the guide. Only one name should
be used consistently.
The mapping table incorrectly maps this template to Yes Condition
the IHE Concern Act and Problem Concern Act.
templateId Yes Medication
N-M: Constraint 3 is incomplete, and as written,
would prohibit the medication template from being
further constrained by other guides.
SHALL contain exactly one [1..1] templateId/@root
(CONF:7499) where templateId/@root =
‘2.16.840.1.113883.10.20.21.4.16’
In Medications, but also in general: N-m: 6.a.i When Yes Text
text/reference/@value is present, it SHALL point to References
the corresponding narrative.
The point is, you SHOULD use reference, and if you
do, you SHALL point to the text.
While this has been discussed greatly, I would note Yes Text
that the relaxation of the constrain from SHALL to References
SHOULD on text/reference in entries results in large
changes that cycle through the entire set of
templates. This single change results in a great
degree of substantive change in the guide that was
unnecessary.
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effectiveTime Yes Medication
N-M: Constraints on medication effectiveTime are
incomplete and contradictory.
N-M: The medication entry only references Yes Medication
medication supply orders, not medication dispense
events. The latter could also be recorded with
medication intent as evidence that the medication is
being used.
repeatNumber Yes Medication
N-m: The discussion of use of repeatNumber is a
dispense (Supply) act is not appropriate in this
section on substanceAdministration.
repeatNumber Yes Medication
N-m: The discussion of use of repeatNumber is a
substance administration act is not appropriate in
this section on supply.
Medication Use None Known Yes Medication
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
Reference doesn't indicate target section number.
The link works fine when reviewing the document
electronically, but isn't necessarily helpful when
working with a printed copy. This general comment
applies generally through the document
If gender is unknown then use a nullFlavor
indicating Unknown?
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It may be helpful to explicitly indicate that the
birthTime MAY be precise to minute.
Need to help out the inexperienced on the nuances
of this field.
NOTE: this refinement is applicable throughout the
document for the effectiveTime element.
It seems like this would also be a good place to
introduce the CDA Level 1, 2, and 3 concepts and
how section templates for which coded entries are
optional vs. required will be indicated (See item #8
below)
Need a better/more complete description of how the
template IDs for optional vs. required coded entries
as well as how that plays into CDA Level 1, 2, and 3
is needed.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 138 March 2003
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Need closing angle bracket to have wellformed
XML
Does this mean that the code itself is required to be
displayed (code/@code) or that the
content/semantics of the code element with its
various attributes SHALL be displayed?
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 139 March 2003
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I think it would be helpful to point out the
possibility of using the "compression" attribute and
using compression on the unstructured content
before using the Base64Encoding. Those who are
not intimate with the ED datatype overlook this
possibility when creating documents and when
dealing with incoming documents.
The concept of templateIds for Required vs.
Optional entries are introduced in Table 31 without
indicating how they fit into the big scheme of things.
It seems like there should be linkage back to
Document Level templates that use the section
templates that are required vs. optional
Incorrect code and displayName indicated? In
section title also.
The Required Entries section should repeat the
constraints from the Optional part but add the
requirement constraint for Entries.
Leaving this as a SHOULD doesn't make sense if
you are going to have a separate template for
Required entries.
This comment applies across the board for
Act/Observation/etc. level templates: No mention is
made of using the displayName attribute or the
originalText element, nor the semantics of one vs.
the other. It may not be necessary to describe in
every section how these attributes/elements are
intended to be used, but it would clear up a lot of
confusion if it were described at least once in this
document and then referred to.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 140 March 2003
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The approach defined in CDA Release 2, section
4.3.5.1 is itself not clear. Is the hash required or not
for "in-document" references? Is it required that the
target of an "in-document" reference (i.e. into the
narrative text of the section) be a <content> element
as CDA Release 2, section 4.3.5.1 suggests? I
would recommend that this be well clarified one way
or the other. I would also recommend that the target
can be any tag/element and not necessarily a
<content> tag. I would also recommend that the
hash SHALL be used in referencing within the
document for consistency with HTML, etc.
Same comments as for item #23 above. Wording for
references in originalText elements should be
standardized throughtout all of section 5.x
What is the semantic meaning of Observation/text
vs. Observation/code/@displayName vs.
Observation/code/originalText? Are any these to be
used as a "comment field"? This document needs to
clearly define these fields throughout and for
Act/text (and all derivatives of Act such as
Observation, substanceAdministration, etc.) the
intent and purpose of the element should be clearly
stated for each template. Note that section 5.6; 5.a
is a good example of describing the use of the <text>
element.
This is a duplicate of Dave Parker's item #39. I also
feel that this is a clarification of vital importance...
The concept of handling comments is introduced in
the HL7 v3 RIM documentation but no examples are
ever given. HITSP C83 formalized that even more
with a template. However, there were still no
examples and people seemed generally unsure of
how to use it inside other template. Therefore I
believe it is truly necessary to use the "MAY
contain...Comment Annotation" conformance in
EVERY section, entry, Act, Observation, etc.
template where it could possibly be used.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 141 March 2003
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This document represents a huge step forward in
collapsing multiple layered specifications to lower
the learning curve for newcomers and reduce the
number of documents that must be searched to
understand what goes where and what it means, etc.
At the very least, a list of references to the various
datatypes used and their definition in the RIM and
CDA documentation as well as a reminder that all
attributes of those datatypes can be used unless there
are specific constraints not to should be made
explicit in this document.
The narrative text of the section can be the basis for Yes
establishing the COMPonent machine readable
entries, or the section can be DeRIVed from the
machine readable entries. The Section is the smallest
complete unit of the structure. Entries are not
complete without their anchoring human readable
form in the Section.
The narrative text of the section can be the basis for Yes
establishing the COMPonent machine readable
entries, or the section can be DeRIVed from the
machine readable entries. The Section is the smallest
complete unit of the structure. Entries are not
complete without their human readable
"counterpart" in the Section. This "pairing" of the
human readable and machine processable is what
creates the potential to be validated. This
potentail is a core principle in the design of a
CDA document.
Rationale: Yes
- the document content module and the entry-level
content elements have instance id's, but the section
does not.
- sections that have no entries need an id to identify
the narrative text that comes in from the section
- Content Consumers have the option of importing
content at the section level and the options requires a
capability to trace the source of the content. Without
an instance id, how could that capability be
implemented?
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 142 March 2003
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No
All other rows in Table 2. use the LOINC code
display name as the Document Type
How would one know if they had received the
complete discharge information? What would tell
you which CDAs to expect? If there were only one
Discharge Summary document, this would be
known to be only 1 expected document. But, with
some many different Dischage Summary documents,
I wouldn't know if I should have collected 1 or 2 or 3
or more to be sure I had all the needed discharge
information. Does the Discharge Summarization
note produced by a physician have different content
from a Discharge summarization produced by an
Attending Physician? If yes? Why?
Should the first occurance of
2.16.840.1.113883.10.20.21.2.4 have a .1 at the end
to make the Entries Required OID distinguised from
the OID that does not require entries?
A search of this OID for the DEV code reveals that
the code is mainly applicable to insulins and
inhalation products. The FDA recommends that this
code system be expanded to include all types of
medical devices regualated by the FDA. The UDI is
in the HL7 SPL.
The FDA Amendments Act specifies the creation of
a Unique Device Identification (UDI) System that
requires the label of devices to bear a unique
identifier which will standardize device
identification and identify the device through
distribution and use. The UDI is in the HL7 SPL.
Without seeing the actual report, rationale, or use
cases, etc that were used to crete this list these
reports appear to be three of the same documents.
There is a potential problem of redundancy, to
inconsistency of coding.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 143 March 2003
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Suggest expanding this section capture other digital
images and information used for diagnostics (i.e.
EKG and hemodynamic waveforms, scalar
measurements, etc.). This section is currently limited
to radiographic images.
The FDA Amendments Act specifies the creation of
a Unique Device Identification (UDI) System that
requires the label of devices to bear a unique
identifier which will standardize device
identification and identify the device through
distribution and use. The UDI is in the HL7 SPL.
The FDA Amendments Act specifies the creation of
a Unique Device Identification (UDI) System that
requires the label of devices to bear a unique
identifier which will standardize device
identification and identify the device through
distribution and use. The UDI is in the HL7 SPL.
The FDA Amendments Act specifies the creation of
a Unique Device Identification (UDI) System that
requires the label of devices to bear a unique
identifier which will standardize device
identification and identify the device through
distribution and use. The UDI is in the HL7 SPL.
The OID for the medical equipment section name is
not the same in table 31 and table 18. Is this correct?
The FDA Amendments Act specifies the creation of
a Unique Device Identification (UDI) System that
requires the label of devices to bear a unique
identifier which will standardize device
identification and identify the device through
distribution and use. The UDI is in the HL7 SPL.
pg 54-66
In addition to the interpretations of the clinicians
(i.e. the reports) and radilology images and
impressions this section could also include the larger
world of digital information from devices other than
radiology (i.e. EKG and hemodynamic waveforms,
scalar measurements, etc.).
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This section should include adverse events resulting
from medical devices (i.e. hip implants, electrical
burns, fragments remaining in patient etc.). The
FDA has a well defined set of Device problem codes
that describe device failures or issues related to the
device that are encountered during the an adverse
event These codes are included in the National
Cancer Institute (NCI) Enterprise Vocabulary
Service (EVS)
The FDA agrees that this section should be included
and capture the unique device identification.
The FDA would like to be involved in this
consolidation effort. The FDA Amendments Act
specifies the creation of a Unique Device
Identification System that requires the label of
devices to bear a unique identifier which will
standardize device identification and identify the
device through distribution and use.
The FDA agrees that this section should be included
and capture the unique device identification. The
FDA would like to be involved in this consolidation
effort.
The FDA suggests that device identification be
inlcuded in the Supply activities CCD templateID
2.16.840.1.113883.10.20.1.34 and/or the product
instance CCD templateId
2.16.840.1.113883.10.20.1.52?
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 145 March 2003
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The FDA agrees that this section should be included
and captures the unique device identification. The
FDa would like to be involved in this consolidation
effort.
The FDA Amendments Act specifies the creation of
a Unique Device Identification (UDI) System that
requires the label of devices to bear a unique
identifier which will standardize device
identification and identify the device through
distribution and use. The UDI is in the HL7 SPL.
Why is the supply activities (templateId
2.16.840.1.113883.10.20.22.4.17 different from the
supply activities CCD templateID under implants
2.16.840.1.113883.10.20.1.34?
The FDA agrees that this section should be included
and captures the unique device identification.
The FDA Amendments Act specifies the creation of
a Unique Device Identification (UDI) System that
requires the label of devices to bear a unique
identifier which will standardize device
identification and identify the device through
distribution and use. The UDI is in the HL7 SPL.
Change may to shall so that the unique device
identification can be included to meet the FDA
statutory requirements.
Will this section link or refer to the HL7 Detailed
Clinical Model for Medical Devices?
Recommend adding FDA use case Adverse Events
Drug Reporting which is in Meaningful Use stage 2
as a new CDA template.
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The Immunization section does not appear to
contain specifications for important immunization
related data. It may be my lack of familiarity with
the content in this document. I would like to see the
immunization section improved and include
examples which illustrate what goes in there or
where else it might go. I would be very happy to
participate in this effort.
Does this limit the use of this guide? When will it
"be complete"?
This is in the sample.
Why is this limited to no more than one religious
affiliation? What if a person follows more than one
religion?
Why is this limited to no more than one race? What
if a person falls into more than one race category?
How does this compare to the raceCode in the
previous conformance statement?
Why limit this to exactly one telecom? What about
home, cell, work, etc. Other participant telecoms are
not limited to exactly one.
Why is this limited to no more than one guardian?
You can legally have more than one guardian.
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This is not how the vast majority of people represent
state abbreviations. Florida is normally "FL",
Alabama is "AL", Federated States of Micronesia is
"FM".
The common state abbreviations are obviously the
most normal to use and they are actually present in
all of the samples within the ballot document and the
provided examples that are part of the ballot
package.
Items (a) and (b) describe how OIDs should be
represented in general. This would apply to all
documents that use OIDs. I recommend moving
items (a) and (b) into a more general area for the
whole document.
With very few exceptions, each ID in the entries is
not described. Is it intented to be an ID internal to
the document, or is it a globally unique ID that has
some other purpose external to the document. For
example, the entry ID is described in the "condition
entry", but it is not described for all entries where an
ID is required.
What does '(open)' mean throughout the guide? No
A-S: "Any SHALL conformance statement may use No
nullFlavor, unless the attribute is explicity required
or the nullFlavor is explicitly disallowed." - Spelling
mistake; should be “explicitly”
A-S: "nullFlavor explictly disallowed" - Spelling No
mistake; should be “explicitly”
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Font size is different than the other 2 listed code No
systems.
sister-inlaw - Should be sister-in-law No
Lake Buena Vista Fl - Should be “Lake Buena Vista, No
FL”
Physical visit address - To be consistent with other No
the names, should be renamed to ‘physical visit
address’.
search - Should be a capitalized search; ‘Search’ No
phonetic - Should be a capitalized phonetic; No
‘Phonetic’
soundex - Should be a capitalized soundex; No
‘Soundex’
templateID - Should be ‘templateId’, not No
‘templateID’
templateID - Should be ‘templateId’, not No
‘templateID’
assignedEntitys - Should be either “assignedEntity” No
or “assignedEntity’s”
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"i. The code MAY be the National Uniform Claims No
Committee Provider Taxonomy Code" - What is the
Code?
8647-0 - Hospital consultations - (scale = nom) - Is No
this assumed to be from the LOINC database?
ClininicalDocument - Spelling mistake. Should be No
‘ClinicalDocument’.
elements - Should be singular; “element” instead of No
“elements”. Otherwise state cardinality of
authorization element.
ServiceEvent - Should be ‘serviceEvent’ No
ServiceEvent - Should be ‘serviceEvent’ No
templateID - Should be ‘templateId’, not No
‘templateID’
2.16.840.1.113883.10.20.21.2.6. - Last period No
should be removed.
2.16.840.1.113883.10.20.21.2.8 - Discrepancy No
between table and section – table 31 lists template
ID as 2.16.840.1.113883.10.20.22.2.8
2.16.840.1.113883.10.20.21.2.9 - Discrepancy No
between table and section – table 31 lists template
ID as 2.16.840.1.113883.10.20.22.2.9
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Font not consistent with the rest of the LOINC codes No
present for each section heading.
10154-3 - Discrepancy between table and section - No
table 31 lists code as 42344-2 in section title
"1. SHALL contain exactly one [1..1] No
templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.1.13.2.
1" (CONF:7832)" - Incorrect templateId one listed
represents Chief Complaint section
"2. SHALL contain exactly one [1..1] No
code/@code="10154-3" Discharge Diet
(CodeSystem: 2.16.840.1.113883.6.1 LOINC)
(CONF:7833)" - Discrepancy between table and
section – table 31 lists code as 42344-2
Multiple occurances of 2.16.840.1.113883.10.20.2.9 No
- Discrepancy between table and section – table 31
lists templateId as 2.16.840.1.113883.10.20.22.2.20
11348-0 - Discrepancy between table and section – No
table 31 lists code as 10164-2
"1. SHALL contain exactly one [1..1] No
templateId/@root="2.16.840.1.113883.10.20.2.9"
(CONF:7828)" - Wrong templateId
"2. SHALL contain exactly one [1..1] No
code/@code="11348-0" History of Past Illness
(CodeSystem: 2.16.840.1.113883.6.1 LOINC)
(CONF:7829)" - Discrepancy between table and
section – table 31 lists code 10164-2
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48765-2 - Discrepancy between table and section – No
table 31 lists code as 11535-2
"1. SHALL contain exactly one [1..1] No
templateId/@root="2.16.840.1.113883.10.20.21.2.6.
1" (CONF:7979)" - Expected -
2.16.840.1.113883.10.20.22.2.24
"2. SHALL contain exactly one [1..1] No
code/@code="48765-2" Allergies, adverse reactions,
alerts (CodeSystem: 2.16.840.1.113883.6.1 LOINC)
(CONF:7980)" - Discrepancy between table and
section – table 31 lists code as 11535-2
Font not consistent with the rest of the LOINC codes No
present for each section heading
Should optional and required sections be listed here. No
Per table 31 - 2.16.840.1.113883.10.20.22.2.2.1
listed
Shouldn't required entries be listed before optional No
entries?
2.16.840.1.113883.10.20.2.10 - Discrepancy No
between table and section – table 31 lists templateId
as 2.16.840.1.113883.10.20.22.2.19
"1. SHALL contain exactly one [1..1] No
templateId/@root="2.16.840.1.113883.10.20.2.10"
(CONF:7806). " - Discrepancy between table and
section – table 31 lists templateId as
2.16.840.1.113883.10.20.22.2.19
Should be Plan of Care No
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Optional Entries has a font consistency issue No
Shouldn't required entries be listed before optional No
entries?
Labeled as 'Procedure Speciments Removed' per No
table 31
Shouldn't required entries be listed before optional No
entries?
Shouldn't required entries be listed before optional No
entries?
Shouldn't required entries be listed before optional No
entries?
Example is empty in Figure 63: Episode observation No
example
Table 50: Procedure Act Status Code Value Set - No
"Completed" - Should be lowercase; i.e. ‘completed’
Table 51: Act Priority Value Set - Preop - What is No
the full name?
"a. This entryRelationship, if present, SHALL No
contain exactly one [1..1] @typeCode="COMP" Has
Compenent (CodeSystem:
2.16.840.1.113883.5.1002
HL7ActRelationshipType) STATIC (CONF:8280)" -
Spelling mistake; should be “Component”
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"a. SHALL contain exactly one [1..1] No
@typeCode="COMP" Has Compenent
(CodeSystem: 2.16.840.1.113883.5.1002
HL7ActRelationshipType) STATIC (CONF:7887)" -
Spelling mistake; should be “Component”
Multiple occurences pf "TemplateId" - Should be No
lowercase templateId; i.e. ‘templateId’ instead of
‘TemplateId’
This section needs to clarify whether PDF No
documents need to conform to PDF-A as stated in
the IHE's XDS-SD (Cross-Transaction
Specifications and Content Specifications, Scanned
Documents Module) profile or are less restrictive to
any version of PDF.
We see a requirement for further guidelines on how No
to handle unstructured documents that contain
referenced documents should be handled in an XDS
repository?
The document combines the concepts of consent to
treat (or be treated) with privacy consent. I think
they are different enough (and complex enough) to
be combined in a single concept. Recommend
separating into 'Informed Consent to Receive
Treatment' and 'Privacy Consent'
traceability: there needs to be a clear method to
know where the conformance criteria orginated and
what, if any, changes have occurred.
inheritance & abstract constructs: there are various
sections and entries which have explict (e.g., vital
signs organizer / results organizer) or implicit (e.g.,
all Observations) relationships to other
sections/entries. Duplicating all of the common
conformance clauses can lead to editorial
management issues and create confusion. also, it
becomes difficult to see when common structures
exist. Creating "abstract" conformance clause sets
and defining conformance clause inheritance would
assist in development and implementation.
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consistency in documentation: possibly a result of
the different sources for different information, but
the conformance clauses are not consistently state.
some tightly related conformance clauses are not
consistent (4.2 optional 3 (blank) verses required 3
(specifies content); there are a few erroneous xPath
statements (search for @code/@code).
conformance clause numbers: will there be any
effort to "re-number" the conformace clauses in a
consistent manner? If so, there are many duplicates
(e.g., all of the classCode="ACT") which could be
consolidated.
If this is to be a continuously evolving catalog then
generally the “voice” should be less rooted in the
"now".
Begs the question: what about all the other IGs and
templates they define? Will they be addressed in a
future project? If so will they create a parallel
document to this one along with all the attendant
maintenance issues? Or extend this artifact?
Please list the MU sections explicitly, alternatively
can note relation to MU Stage 1, Stage 2, etc., as
“metadata” for all templates (within each section) as
this guide moves forward. The FR sections are not
identified in this document.
This whole section describes the process used,
which is not really useful for implementation. What
would be better is info on the CDA template
architecture/concept this IG establishes.
Removed "of" and plurality of types.
Or maybe it is an incomplete sentence? It's not clear
what the list of document types is being discussed.
Just this project list or all document types going
forward?
Will this document become the normative library of
consolidated templates? See first comment on voice
of this document.
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The word “pre-review” doesn’t appear in this guide
again. How is the flagging accomplished?
Also, please provide an example in document
conventions.
Example? Will this explain the bracket syntax that
follows each template section title?
Suggest all of these tips be collected and presented
in a Document Conventions Section.
It's more factual to say this concept is from the
standard.
These statements aren't relevant to the end result of
the guide, as any differences in output should be
normalized in this document.
Explain how this is done, e.g., “.. identified by the
string “(open)” at the end of the template ID." See
the comment about a Document Conventions
section…
The term "controlled" is introduced but not defined,
nor is any explanation of an "uncontrolled"
vocabulary offered.
Please provide an example of the identifier.
Document conventions would be a nice thing to
have… :-)
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Please provide an example of an extended xpath
statement.
This section and the next both say "this 'thing'
appears as a monospaced font", but there are no
examples to differentiate them.
File names are inconsistent, if they're all sample
files, they should be noted as such.
Generally throughout the template sections, there is
a lack of tying the CDA markup back to "business
names" as requested by the participants (they cited
C83, C154 as a sources).
The conformance strength level (shall, should)
should not correlated to the cardinality value.
Cardinality specifies the data element range of
occurrence, the conformance level of strength (shall,
should) indicates the stength of error if the
cardinality range was violated by a data element in a
CDA instance.
Is the default nullFlavor rule for "SHOULD" also
applicable to SHOULD?
Inconsistent wording style for the similiar time
constraint between Conf 5257 and (conf 5299, conf
5300)
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This constraint is not clear regarding:
1. there is no description for the namespace "sdwg:"
in the IG, and how should it be handle. A CDA
instance with extended namespace will not pass
CDA.xsd validation, for such case, is the CDA
instance still considered as a valid CDS xml?
2. there is no description for the reason of why there
is a special constraint using extended namespace for
"raceCode", why there is no similar extended-
namespace-based constraint for ethnicGroupCode?
Recheck for typos, e.g. clincial, explicity
Recheck for consistency of language, e.g. “This
chapter describes...” vs “This chapter defines”
(defines is preferable)
In introductory material explain the criteria for
inclusion of MAY constraints. Consider recasting
some MAYs as guidance. Example 1: A Reaction
Observation MAY contain a Severity Observation –
but so “may” almost any other clinical statement.
See by contrast 4.21, which gives MAY-type
guidance in text: the constraints are SHALL and
SHOULD. Example 2: CONF:7555 MAY contain
0..1 repeatNumber – this is base CDA, mentioned
in order to support a narrative constraint explaining
interpretations of repeatNumber. Example 3: MAY
contain 0..1 approachSiteCode – this is base CDA,
mentioned in order to support a constraint on the
values.
Document the effect of the SDWG 3/17 decision to
include numeric ranges for cardinality as normative
and to interpret conformance verbs separately from
cardinality. This allows combinations such as MAY
1..1 which give a finer-grained control during
validation but, being previously unused, need
interpretation for those familiar with CDA as well as
those new to it.
Make the usage of conformance verb and cardinality
consistent throughout. Most constraints use the
existing practice (e.g. MAY 0..1), some use the
newer practice (e.g. MAY 1..1).
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Recast the constraints which specify /@code in the
constraint context, after determining whether they
intentionally preclude a nullFlavor. The
Consolidation team proposed that an explicit
constraint be present to preclude a nullFlavor.
Related to #6 – Consider separating the cardinality
of a node/field from the cardinality of its content.
When the verb is other than SHALL this explicitness
adds clarity, e.g. SHOULD 1..1 code which, if
present, SHOULD be valued and, if valued, the
value SHALL be selected from such-and-such a
value-set. Separating node cardinality from content
cardinality may provide a computable approach for
distinguishing Mandatory from Required or
Required from Optional, etc.
This would remove some ambiguities, e.g. CONF:
7668: “MAY contain zero or one [0..1]
priorityCode/@code, which SHALL be selected
from ValueSet 2.16.840.1.113883.1.11.16866
ActPriority DYNAMIC”. Issue is that
<priorityCode nullFlavor='NI'/> is valid according
to this constraint, but it's not clear whether it's
intended to be.
The headings currently state that the entries in the
first group are optional (“Optional Entries”) and the
entries in the second group are required (“Required
Entries”). That is not the intended meaning.
Review the desirability of doubled templateIds and
make the IG take a consistent approach. The
Medications Section “with entries” and some others
require two templateIds – one to satisfy conformance
to the section without entries, and a second for the
specialization that requires the appropriate entries. It
also repeats constraints of its parent template
(CONF:7569, 7570, 7571, 7574, 7575; code, title,
text, etc.). This is confusing. See by contrast 4.40
which does not duplicate the shared constraints, and
does not double templateIds but at the expense of
requiring no templateId when entries are optional. A
more desirable approach would require only a single
templateId for each form and yet not duplicate
constraints.
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Review the expression of mutually-exclusive choices
to eliminate conflicts. Example: CONF:7572-3
appear to be in conflict with 7574-5. The first pair
SHALL at least one Medication Activity. The
second pair MAY a Medication Use – None Known
. The narrative constraint 7576 which states that one
or the other must be present does not resolve this.
Options include: express the alternatives as
SHOULD/MAY plus an additional constraint to say
one or another must be present; support multiple
alternatives computably; eliminate the need for an
alternative by providing a code “None known” for
use in Medication Activity. Cf. 7515-17-29.
Make conformance verbs for entries in “Optional
Entries” vs “Required Entries” consistent or explain
when they are not. Entries Optional example: In
Sections 4.40, 4.48, 4.50, entries are not mentioned,
MAY, and SHOULD respectively. Entries Required
example: In Sections 4.40, 4.48, 4.50, entries are
SHOULD, SHALL, and SHALL respectively.
Move CONF-144 to be a subordinate of CONF-143.
Check for presence and format of constraint #s. In
section 4.40, under “Required Entries”, two
constraints have no constraint #, and one has an
unusual form (CONF-CONSOL-549).
There are two constraint formats. Correct the one
which duplicates the term. Example, section 5.5,
constraint 7a – Contains @typeCode="SUBJ" SUBJ
(has subject).
The section “Condition Entry” begins “This section
describes...” Does this para belong someplace else?
Do not title clinical statements “...Entry”. Example:
5.60, Condition Entry. (In this case, the templates
Condition & Condition Entry perhaps should be
titled Condition Act, Condition Observation –
similar to the pattern of Problem Act & Problem
Observation.)
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Relationship of similar templates is not always clear.
Example: Condition (Act), Condition (Observation).
The template describes talk about “problems”. There
is also a Problem Act & Problem Observation. Since
these templates may be used outside their original
context, it would be helpful for the template
descriptions to mention closely-similar templates
and provide a way to know which is appropriate
when.
Where the constraint context is an attribute, omit
cardinality which is irrelevant to attributes. E.g.
SHALL contain exactly one [1..1[ code/@code
Would it be useful to make more use of named sub-
entry patterns such as Header Address? Example:
CONF:7501-2-3 (should contain a reference to the
corresponding narrative) could be expressed as a
single constraint such as SHOULD contain a
NarrativePointer.
The templateId in the subheading is ...21.4.8. The
templateId required by constraint is ...22.4.8. The
Reaction Observation uses ...22.4.8. (CONF:7582).
The correction also needs to be made in Figure 1,
Constraints Format Example.
Resolve inconsistencies in constraints format. E.g.
section 5.5, list item 8a Contains
@typeCode="SUBJ" SUBJ (has subject) vs list
item 8b SHALL contain exactly one [1..1]
@inversionInd = "true"
Format the code and insert “The” at the start.
Make this useful guidance easier to follow by
breaking it into 3 paras.
This paragraph contains a bolded MAY. Practice is
to avoid using conformance verbs in narrative text,
and especially not to give them the same formatting
as in constraints.
2.1.6 requires name, 3.3.1.4 does not. Should these
specifications for health chart be aligned?
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The XPath is wrong (duplicates responsibleParty)
and the final cardinality is both difficult in English
and misleading in logic (allows >1 assignedPerson,
>1 representedOrganization)
Review language of “If” constraints. It is clearer to
employ "If" only for a conditional that can be tested
within the document. For real-world conditions, use
"When" or "To record...", and cast these as guidance
to the data recorder, i.e. in paragraph text, not as
constraints. Examples: If only the date and the
length of procedure are known --> When only the
date and the length of procedure are known. If the
phone is an office phone,... --> To record that the
phone is an office phone,...
Review overlap of header constraints with General
Header Constraints. Example: 8488
serviceEvent/effectiveTime in a Consent. Most of
the subconstraint is identical to GH 7602.
Fix the XPath here and elsewhere if it recurs.
Fix the XPath and resolve which is the intended
constraint - 28570-0 or the value set?
This template name is not user-friendly. The need is
to distinguish three cases, currently titled Procedure
Activity Procedure, Procedure Activity Observation,
and Procedure Activity Act. Some acceptable
variation of the following concepts might be found:
Treating Procedure, Informing Procedure, Unclassed
Procedure.
Review the consolidated set of template names: Do
they have a regular pattern and allude to the
differences among similar templates?
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In the template description, should “(post-
condition)” be “(post-procedure)”?
Needs fix – the XML is wrong -- "This code @code"
but there was no @code in 7656
DIR was designed to be a universal realm document.
This was explicitly stated by DICOM WG 6, and
was the key reason why we could not use the US
realm header.
I suggest removing the requirement that DIR follow
the universal realm header, perhaps moving the non-
US specific stuff into a separate template that may
be used for universal realm documents.
Fix font size
Incorrect templateId used
This HL7 valueSet includes pharma name parts. We
need to create a subset of this valueSet including
only those applicable to person names:
AC academic
AD adopted
BR birth
CL callme
IN initial
LS legal status
NB nobility
PR professional
SP spouse
TITLE title
VV voorvoegsel
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Should be a valueSet binding
Only minors or other dependents need to have a
guardian
I don't see differences in the conformance statements
over the participant in the US Realm header -now
that they are in the consolidated guide - consider not
repeating. (note minor differences in template
descripton and
Consider creating separate templates for each of the
participants contained in the header. This will be
better for re-use across current and new documents.
Allergy/Alert Observation template - link is broken
Negation Ind ="true" is an acceptablle way to asssert
that something was NOT observed. Not likeley to
have a controlled term in an EHR that is "no hx of
chicken pox". It will be a clinical assertion.
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This is an entry - not a section
condition wrapper should not be required - a
problem (condition) entry should be able to stand on
its own for sending simple instances of a problem or
symptom. Update to a MAY
Therefore this section contains procedure templates
represented with three RIM classes: Act,
Observation and Procedure
Please add tables of templates: At least Templates by
Containment and perhapsTemplates Organized
Hierarchically.
The Discharge Diagnosis section/entry describes the
relevant problems or diagnoses at the time of
discharge that occurred during the hospitalization or
that need to be followed after hospitalization. This
section includes an optional entry to record patient
conditions
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Result organizer should not be required. Allow
simple send of a single result observation without an
organizer
style (font) of narrative (primitive) conformance
statements should be consistent with other parts of
the guide
primitive conformance statements should be written
with proper syntax
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primitive conformance statements should be written
with proper syntax
What does " SHOULD ... one [1..1] " mean and how
would this be represented in a UML model (RMIM)
snippet and be differentiated from SHALL 1..1?
There are 2 "service location value sets in HL7 -
they should either be consolidated or we should use
the VALUE SET: HealthcareServiceLocation
(2.16.840.1.113883.1.11.20275) in all IGs as it is
updated regularly and used by CDC for reporting of
HAI and other quality metrics where location is
required
this modeCode and valueSet is OK to have - not sure
why it is explicitly stated (it’s a MAY) and is not
highly valueable from a clinical perspective whereas
"proficiencyLevelCode" with valueSet of
LanguageAbilityProficiency
(2.16.840.1.113883.1.11.12199)
(Example:Excellent, good, fair, poor.) is much more
useful clinically especially in transfer of care
situations allowing clinicans to prepare for the
patient in terms of interpreters etc.. It is not
judgemental.
links don’t work
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This extensive commenting would be better as a
general comment about effectiveTime rather than
amongst computable conformance statements
Does this mean the implementer has to look to C83
for further information?
What does this mean? Also this is an entry template
- not a section template
what is the "technical framework" - should there be
a link here?
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negationInd is a valid way to explicitly state
something did not occur.
Why is this called a condition entry instead of a
problem entry?
The section should include a sub-section the General
Header Template and additional sections on consist
approach to aspects not constrained by the General
Header Template. For example, there is already a
section on use of serviceEvent.
Add a subsection on the use of document type code.
Explain preference for post-coordination of
document type with procedures and service events.
Review the descriptions in the 9 document types for
consistency.
What is the status of the existing guides after the
Consolidation IG is published?
Remove from Optional column, Vital Signs are
required in H&P.
double-check Vital Signs Observation, allergies,
results section for mismatch.
Should be 22.4.**, not 20.21.4.**
Add componentOf example to H&P sample
Add vital signs, allergies, results, general status
example sections to H&P sample
How do you specify no known allergies? In the case
of “No Known Allergies”, is the outer act
necessary?
• Bullets 1 and 2 in the History of Present Illness
section on page 115, reflect the same values as the
History of Past Illness section on the previous page.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 169 March 2003
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Reason for Visit Section 29299-5
Missing LOINC code in CONF Statement 7837
Is the intent to cover all of MU Stages 1,2,3 with
this ballot? This should be properly scoped to Stage
1 since that is all that is defined currently.
What is being only partially harmonized? This is a
general statement that leads to ambiguity.
This document will need additional navigational
capabilities with links between various artifacts. For
instance, there should be hyperlinks from Table 18
to all the specific sections that are referenced (not
just to the document type). And the links should be
bi-directional - for instance between "Result
Observation" definition and "Vital Sign
Observation" definition and back. Without this
capability, this document will be very difficult to
use.
The name is inconsistent - leading to navigation
problems between this table entry and section 4.37.
The name is inconsistent - leading to navigation
problems between this table entry and the section
4.38.
There needs to be more materials provided with the
ballot package in order to evaluate the specification
more easily. There are significant consistency issues
throughout the document. I have captured a number
of them, but do not include every single instance.
My comments should be applied through the entirety
of the document and there needs to be a
conformance statement consistency review as part of
ballot reconciliation.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 170 March 2003
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This specifications makes a large number of Yes
substantive changes from the specifications of which
it is derived. In order to properly review and
understand the nature and potential impact of all of
these changes, it is necessary to have a properly
documented change log that explicitly points out all
of the changes from the previous materials
(specifications including CCD, IHE PCC and HITSP
C83 etc.). This is also very important for
implementers whom will need to change their
implementations to support a modified specification.
The word Control is missing from the CDC title.
There is often confusion regarding the requirement
of entries when no data is available.(e.g. No lab
results on file). This confusion has been
compounded by MU requiring certain sections (e.g.
diagnostic test results). The question implementers
often ask is, if I do not have any information on file
for a section that requires entries, how do I produce
a valid document and note that there are no entries.
There needs to be guidance in this area (either
stating that the section need not be present (though
systems need to be able to create the section properly
if information does exist), or that the section must
always be present and explicitly mention the
requirements of the entry the denotes the no
information is on file or is included in the document.
There will be future specifications that make
reference to this guide. As such there will be a need
to pull in conformance statements from multiple
sources (e.g. this guide and a document type guide
that further constrains this guide for a specific
document type). In this case, it will be necessary to
uniquely identify conformance constraints across
multiple guides. Is there a mechanism for doing so?
Perhaps put a guide identifier as part of the
conformance ID?
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 171 March 2003
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It is preferable to specify each requirement in a
separate conformance statement for the purposes of
clarity. In section 1.7.2, example conformance
statement group 5, does this well. Example 4 is
confusing as it seems to indicate an attribute value
requirement yet does not include an element level
requirement. The attribute is only valid as a member
of an element. The conformance statements should
clearly state the element level requirement
(cardinality), and then the attribute requirements
(e.g. code="ABC" from codeSystem XYZ.)
Element cardinality requirements and vocabulary
requirements should be indicated as separate
requirements (preferably vocabulary requirements
will be listed as sub-items to the element level
cardinality requirement). This will help reduce
confusion as to whether the criteria is meant to
address an element level need (cardinality), or a
vocabulary need (may not be clear when it is a
vocabulary need as to whether the element is also
required, unless they are broken into separate
conformance statements). This needs to be applied
consistently throughout the document. I have
included some examples in some of my comments to
follow, but this needs to be applied throughout the
document (the proposed and existing wording to the
left is provided only to illustrate the point.
This section mentions open and closed templates. I
see no examples of closed templates in this
document (I would vote negatively on any closed
templates because of the purpose of this
specification). It would be nice to let
readers/implementers know that there are no closed
templates contained within this guide.
There are no explanations for conformance
requirements. In order to ensure proper
implementation it is important to indicate the intent
and purpose of each conformance criteria in order to
help ensure proper implementation.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 172 March 2003
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Not every section and entry contains an example.
All conformance statements need to contain a full
sample (or set of samples, where needed to
demonstrate differing conditions) in order to
properly illustrate the requirements. This will help
insure proper implementation.
templateId's need to have an indication as to their
context. TemplateIds can be specified at any
number of levels (e.g. section template, entry
template, entryRelationship template etc.) The full
context of each templateId needs to be clearly stated
(perhaps as the first constraint for the template).
This is done in places, but is not consistent. This
needs to be applied across the entire document.
Only one UML diagram exists (for problem list) in
this guide. There should be a UML diagram for
each section and entry set.
The codeSystem needs to always be indicated and
clear. There should be an explanation of how to
read the codeSystem requirement in section 1.7.5.
For example, "if the following constraint is specified
“@moodCode="EVN" Event (CodeSystem:
2.16.840.1.113883.5.1001 HL7ActMood)”
codeSystem="2.16.840.1.113883.5.1001" and
codeSystemName="HL7ActMood"
Most conformance statements about entity
identifiers ("id" element), restrict the cardinality to
only 1 id. There are many instances where an entity
is likely to have more than one id dependent on the
assigning authority. Either relax all the
requirements are specify why only one id is allowed,
and the source of what that identifier is supposed to
be. the existing and proposed wording to the left is
provided as an example (there are some examples in
further comments to help illustrate). This comment
is included to be applied to all id elements (rather
than including comments ad nauseum).
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 173 March 2003
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There is no indication in this document as to
whether the value sets are closed or open (
closed=value must be contained within this value
set; open=value set is minimal and recommended set
but use of other codes within the code system are
allowed). This document needs to indicate whether
all value sets are closed or open, or provide better
guidance how the value set requirements are to be
interpreted. (An open value set could potentially be
handled by having a conformance statement that
states the codeSystem is ABC and another statement
that says the code SHOULD be from the value set.).
This is acceptable, but needs to be made clear to the
reader.
It is not clear in this section as to whether non-
consolidated items are present for reference only or
represent actual requirements for conformant
documents. This needs to be explicitly stated,
MU_CCDSample.xml (file name incorrect). This
document does not conform to C32 MU nor HITSP
C32 (2.5). This entry is confusing. What it
represents should be clearly denoted. If this is
supposed to be an MU document, it needs to
conform/validate as such.
There are two requirements here. 1) that there shall
be 1 realmCode. 2) that the
realmCode/@code="US". As currently written the
requirement is confusing
It may be clearer if we structured this item as an
item that one and only one like it must be present.
Suggest using the conformance verbs and structured
used elsewhere in this guide.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 174 March 2003
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Suggest separating out all conformance requirements
into separate statements. (this is done in 2.1.1-
12.a.iv.3
Suggest separating out all conformance requirements
into separate statements.
Suggest separating out all conformance requirements
into separate statements.
Does this preclude the possibility of having a
country code? Table 3 does not provide an example
where this is indicated. If the country code is
allowed, an example should be provided in order to
reduce confusion.
Suggest using the element name unmodified (do not
append an element name with s to indicate multiple
instances, but rather reword the requirement. This
comment should be applied generally across the
document. There needs to be consistency.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 175 March 2003
V3 Ballot Submission/Resolution Form
As written this statement does not allow for a
nullFlavor (if the patient gender is unknown or not
documented), per the rules specified in section 1.7.6.
The new wording requires an
administrativeGenderCode, and if the @code is
included, it SHALL be from the value set specified
There is a new namespace included that is not
defined anywhere in this document. The name
space needs to be described. Note that this
namespace is not consistent with C83 4.1.1 (sdtc vs
sdwg). Potential compatibility issues?
The purpose of this requirement is not clear. Why
should there not be more than 1 guardian (children
may have more than one guardian
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 176 March 2003
V3 Ballot Submission/Resolution Form
It is not clear why a guardian must have 1 and only 1
telecom.
The wording "if present" is not consistent with other
parts of this document. Since the parent has a
cardinality of [0..1] it is understood that the child
requirements are only in the instance where the
element is present. This comment should be applied
generally across the document. There needs to be
consistency.
It is not clear why only one id is allowed.
It is not clear why only one id is allowed.
It is not clear why only one id is allowed.
It is not clear why only one id is allowed.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 177 March 2003
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The source of this dynamic value set is not
indicated. Who is the authoring authority and where
can the current set be procured from.
The source of this dynamic value set is not
indicated. Who is the authoring authority and where
can the current set be procured from.
templateId is not an element allowed in the addr
(type "AD") element. Including a templateId is
confusing. What is the requirement and use of the
templateId? Where does this templateId need to be
specified?
templateId is not an element allowed in the name
(type "PN") element. Including a templateId is
confusing. What is the requirement and use of the
templateId? Where does this templateId need to be
specified?
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 178 March 2003
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Requirements need to be separated and consistent
with the rest of the guide
Certain templates are listed as required, however,
there is no indication as to how to specify that there
is no data to be included in the document (e.g. if
creating a CCD, but there are no results that are
clinically relevant to the purpose the document is
being created). This needs to be clearly specified in
order to enable consistent and correct
implementations.
Table 18 indicates that there are several required
sections in the CCD document type, yet section 4
SECTION LEVEL TEMPLATES Table 31 states
that all of the sections are optional for CCD. The
difference needs to be reconciled.
The specifications included in this guide are not
C32, nor is it backward compatible to C32. Unless
this document is proposing a new version of C32, it
is not correct to assert C32 here.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 179 March 2003
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as currently written, it does not require that the
templateId be explicitly included in the document.
as currently written, it does not require that the
templateId be explicitly included in the document.
The context already suggest that the element may
not be present, so there is no need to indicate "if
present". Requirements need to be separated
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 180 March 2003
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May need additional wordsmithing.
It is not clear as to whether this is a requirement or a
description of the requirement above.
If this is a conformance statement as to an allowed
element, it should be written as such
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 181 March 2003
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It is not clear how to read table 31, and if there are
specific requirements being listed. Each
requirements should have an identifier.
There may be more than one advance directive. The
statement that it can contain exactly one seems
confusing. Why is this being mentioned? Why not
zero or more? One or more? The statement as is
does not mentioning any requirements or really
providing any guidance.
Why would there be a limit to the number of
immunization entries? This is done in numerous
places in this document. All need to be reviewed.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 182 March 2003
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mmittee Resolution Ballot Comment Tracking
Against
Abstain
Change Substantive On Behalf of Submitter
For
Responsible Person Applied Change Submitted By Organization On behalf of Email Tracking ID Referred To
Austin Kreisler
SAIC
Austin Kreisler
SAIC
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 183 March 2003
V3 Ballot Submission/Resolution Form
Austin Kreisler
SAIC
Doug Pratt
Siemens
Doug Pratt
Siemens
Doug Pratt
Siemens
Doug Pratt
Siemens
Doug Pratt
Siemens
Doug Pratt
Siemens
Doug Pratt
Siemens
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 184 March 2003
V3 Ballot Submission/Resolution Form
Doug Pratt
Siemens
Doug Pratt
Siemens
Doug Pratt
Siemens
Doug Pratt
Siemens
Doug Pratt
Siemens
Doug Pratt
Siemens
Doug Pratt
Siemens
Doug Pratt
Siemens
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 185 March 2003
V3 Ballot Submission/Resolution Form
Doug Pratt
Siemens
Doug Pratt
Siemens
Doug Pratt
Siemens
Doug Pratt
Siemens
Helmut.Koenig@s
Doug Pratt Helmut Koenig
iemens.com
Siemens
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 186 March 2003
V3 Ballot Submission/Resolution Form
Helmut.Koenig@s
Doug Pratt Helmut Koenig
iemens.com
Siemens
David.Tao@siem
Doug Pratt David Tao
ens.com
Siemens
David.Tao@siem
Doug Pratt David Tao
ens.com
Siemens
David.Tao@siem
Doug Pratt David Tao
ens.com
Siemens
David.Tao@siem
Doug Pratt David Tao
ens.com
Siemens
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 187 March 2003
V3 Ballot Submission/Resolution Form
David.Tao@siem
Doug Pratt David Tao
ens.com
Siemens
David.Tao@siem
Doug Pratt David Tao
ens.com
Siemens
David.Tao@siem
Doug Pratt David Tao
ens.com
Siemens
David.Tao@siem
Doug Pratt David Tao
ens.com
Siemens
David.Tao@siem
Doug Pratt David Tao
ens.com
Siemens
David.Tao@siem
Doug Pratt David Tao
ens.com
Siemens
David.Tao@siem
Doug Pratt David Tao
ens.com
Siemens
David.Tao@siem
Doug Pratt David Tao
ens.com
Siemens
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 188 March 2003
V3 Ballot Submission/Resolution Form
David.Tao@siem
Doug Pratt David Tao
ens.com
Siemens
David.Tao@siem
Doug Pratt David Tao
ens.com
Siemens
David.Tao@siem
Doug Pratt David Tao
ens.com
Siemens
David.Tao@siem
Doug Pratt David Tao
ens.com
Siemens
David.Tao@siem
Doug Pratt David Tao
ens.com
Siemens
David.Tao@siem
Doug Pratt David Tao
ens.com
Siemens
David.Tao@siem
Doug Pratt David Tao
ens.com
Siemens
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 189 March 2003
V3 Ballot Submission/Resolution Form
David.Tao@siem
Doug Pratt David Tao
ens.com
Siemens
David.Tao@siem
Doug Pratt David Tao
ens.com
Siemens
David.Tao@siem
Doug Pratt David Tao
ens.com
Siemens
David.Tao@siem
Doug Pratt David Tao
ens.com
Siemens
David.Tao@siem
Doug Pratt David Tao
ens.com
Siemens
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 190 March 2003
V3 Ballot Submission/Resolution Form
David.Tao@siem
Doug Pratt David Tao
ens.com
Siemens
David.Tao@siem
Doug Pratt David Tao
ens.com
Siemens
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 191 March 2003
V3 Ballot Submission/Resolution Form
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD Evolvent
Technologies Inc.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 192 March 2003
V3 Ballot Submission/Resolution Form
David Parker, MD Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 193 March 2003
V3 Ballot Submission/Resolution Form
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD Evolvent
Technologies Inc.
David Parker, MD Evolvent
Technologies Inc.
David Parker, MD Evolvent
Technologies Inc.
David Parker, MD Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD Evolvent
Technologies Inc.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 194 March 2003
V3 Ballot Submission/Resolution Form
David Parker, MD Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 195 March 2003
V3 Ballot Submission/Resolution Form
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
David Parker, MD
Evolvent
Technologies Inc.
Diane Juskelis Margaret Dittloff mkd@cbord.com
Elaine Ayres -
Diane Juskelis American Dietetic EAyres@cc.nih.gov
Association
Diane Juskelis
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 196 March 2003
V3 Ballot Submission/Resolution Form
Diane Juskelis Margaret Dittloff mkd@cbord.com
Diane Juskelis Margaret Dittloff mkd@cbord.com
Diane Juskelis Margaret Dittloff mkd@cbord.com
Diane Juskelis Margaret Dittloff mkd@cbord.com
Diane Juskelis Margaret Dittloff mkd@cbord.com
Elaine Ayres -
Diane Juskelis American Dietetic EAyres@cc.nih.gov
Association
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 197 March 2003
V3 Ballot Submission/Resolution Form
Diane Juskelis Margaret Dittloff mkd@cbord.com
Diane Juskelis Margaret Dittloff mkd@cbord.com
Diane Juskelis Margaret Dittloff mkd@cbord.com
Diane Juskelis Margaret Dittloff mkd@cbord.com
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 198 March 2003
V3 Ballot Submission/Resolution Form
Emma Jones on
behalf of
Allscripts
Allscripts
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 199 March 2003
V3 Ballot Submission/Resolution Form
Emma Jones on
behalf of
Allscripts
Allscripts
Emma Jones on
behalf of
Allscripts
Allscripts
Emma Jones on
behalf of
Allscripts
Allscripts
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 200 March 2003
V3 Ballot Submission/Resolution Form
Emma Jones on
behalf of
Allscripts
Allscripts
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 201 March 2003
V3 Ballot Submission/Resolution Form
Emma Jones on
behalf of
Allscripts
Allscripts
Emma Jones on
behalf of
Allscripts
Allscripts
Emma Jones on
behalf of
Allscripts
Allscripts
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 202 March 2003
V3 Ballot Submission/Resolution Form
Freida Hall
Quest Diagnostics
Freida Hall
Quest Diagnostics
Freida Hall
Quest Diagnostics
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 203 March 2003
V3 Ballot Submission/Resolution Form
Freida Hall
Quest Diagnostics
Freida Hall
Quest Diagnostics
Freida Hall
Quest Diagnostics
Freida Hall
Quest Diagnostics
Gaby Jewell
Cerner
Corporation
Cerner
Gaby Jewell
Corporation
Cerner
Gaby Jewell
Corporation
Gaby Jewell
Cerner
Corporation
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 204 March 2003
V3 Ballot Submission/Resolution Form
Gaby Jewell
Cerner
Corporation
Cerner
Gaby Jewell
Corporation
Gaby Jewell Cerner
Corporation
Gaby Jewell Cerner
Corporation
US Department of
Gregg Seppala
Veterans Affairs
US Department of David.Carlson@v
Gregg Seppala David Carlson
Veterans Affairs a.gov
US Department of David.Carlson@v
Gregg Seppala David Carlson
Veterans Affairs a.gov
US Department of David.Carlson@v
Gregg Seppala David Carlson
Veterans Affairs a.gov
US Department of David.Carlson@v
Gregg Seppala David Carlson
Veterans Affairs a.gov
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 205 March 2003
V3 Ballot Submission/Resolution Form
US Department of David.Carlson@v
Gregg Seppala David Carlson
Veterans Affairs a.gov
US Department of David.Carlson@v
Gregg Seppala David Carlson
Veterans Affairs a.gov
US Department of David.Carlson@v
Gregg Seppala David Carlson
Veterans Affairs a.gov
US Department of matthew.greene2
Gregg Seppala Matthew Greene
Veterans Affairs @va.gov
US Department of matthew.greene2
Gregg Seppala Matthew Greene
Veterans Affairs @va.gov
US Department of matthew.greene2
Gregg Seppala Matthew Greene
Veterans Affairs @va.gov
US Department of matthew.greene2
Gregg Seppala Matthew Greene
Veterans Affairs @va.gov
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 206 March 2003
V3 Ballot Submission/Resolution Form
US Department of Jaylyle@gmail.co
Gregg Seppala Jay Lyle
Veterans Affairs m
US Department of Jaylyle@gmail.co
Gregg Seppala Jay Lyle
Veterans Affairs m
US Department of Jaylyle@gmail.co
Gregg Seppala Jay Lyle
Veterans Affairs m
US Department of Jaylyle@gmail.co
Gregg Seppala Jay Lyle
Veterans Affairs m
US Department of Jaylyle@gmail.co
Gregg Seppala Jay Lyle
Veterans Affairs m
US Department of Jaylyle@gmail.co
Gregg Seppala Jay Lyle
Veterans Affairs m
US Department of Jaylyle@gmail.co
Gregg Seppala Jay Lyle
Veterans Affairs m
US Department of Jaylyle@gmail.co
Gregg Seppala Jay Lyle
Veterans Affairs m
US Department of Jaylyle@gmail.co
Gregg Seppala Jay Lyle
Veterans Affairs m
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 207 March 2003
V3 Ballot Submission/Resolution Form
US Department of Jaylyle@gmail.co
Gregg Seppala Jay Lyle
Veterans Affairs m
US Department of Jaylyle@gmail.co
Gregg Seppala Jay Lyle
Veterans Affairs m
US Department of Jaylyle@gmail.co
Gregg Seppala Jay Lyle
Veterans Affairs m
US Department of Jaylyle@gmail.co
Gregg Seppala Jay Lyle
Veterans Affairs m
US Department of Jaylyle@gmail.co
Gregg Seppala Jay Lyle
Veterans Affairs m
US Department of Jaylyle@gmail.co
Gregg Seppala Jay Lyle
Veterans Affairs m
US Department of Jaylyle@gmail.co
Gregg Seppala Jay Lyle
Veterans Affairs m
US Department of Jaylyle@gmail.co
Gregg Seppala Jay Lyle
Veterans Affairs m
US Department of Jaylyle@gmail.co
Gregg Seppala Jay Lyle
Veterans Affairs m
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 208 March 2003
V3 Ballot Submission/Resolution Form
US Department of Jaylyle@gmail.co
Gregg Seppala Jay Lyle
Veterans Affairs m
US Department of Jaylyle@gmail.co
Gregg Seppala Jay Lyle
Veterans Affairs m
US Department of Jaylyle@gmail.co
Gregg Seppala Jay Lyle
Veterans Affairs m
US Department of Serafina.Versaggi
Gregg Seppala Serafina Versaggi
Veterans Affairs @va.gov
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 209 March 2003
V3 Ballot Submission/Resolution Form
US Department of Serafina.Versaggi
Gregg Seppala Serafina Versaggi
Veterans Affairs @va.gov
US Department of Serafina.Versaggi
Gregg Seppala Serafina Versaggi
Veterans Affairs @va.gov
US Department of Serafina.Versaggi
Gregg Seppala Serafina Versaggi
Veterans Affairs @va.gov
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 210 March 2003
V3 Ballot Submission/Resolution Form
US Department of Serafina.Versaggi
Gregg Seppala Serafina Versaggi
Veterans Affairs @va.gov
US Department of Serafina.Versaggi
Gregg Seppala Serafina Versaggi
Veterans Affairs @va.gov
US Department of Serafina.Versaggi
Gregg Seppala Serafina Versaggi
Veterans Affairs @va.gov
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 211 March 2003
V3 Ballot Submission/Resolution Form
US Department of Serafina.Versaggi
Gregg Seppala Serafina Versaggi
Veterans Affairs @va.gov
US Department of Serafina.Versaggi
Gregg Seppala Serafina Versaggi
Veterans Affairs @va.gov
US Department of Serafina.Versaggi
Gregg Seppala Serafina Versaggi
Veterans Affairs @va.gov
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 212 March 2003
V3 Ballot Submission/Resolution Form
US Department of Serafina.Versaggi
Gregg Seppala Serafina Versaggi
Veterans Affairs @va.gov
US Department of
Serafina.Versaggi
Gregg Seppala Veterans Affairs Serafina Versaggi
@va.gov
Harry Solomon
GE Healthcare
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 213 March 2003
V3 Ballot Submission/Resolution Form
Harry Solomon
GE Healthcare
Harry Solomon
GE Healthcare
Harry Solomon
GE Healthcare
Harry Solomon
GE Healthcare
Harry Solomon
GE Healthcare
Harry Solomon
GE Healthcare
Harry Solomon
GE Healthcare
Harry Solomon
GE Healthcare
Harry Solomon
GE Healthcare
Harry Solomon
GE Healthcare
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 214 March 2003
V3 Ballot Submission/Resolution Form
Harry Solomon
GE Healthcare
Harry Solomon
GE Healthcare
Harry Solomon
GE Healthcare
Harry Solomon
GE Healthcare
Harry Solomon
GE Healthcare
Harry Solomon
GE Healthcare
Harry Solomon
GE Healthcare
Harry Solomon
GE Healthcare
Harry Solomon
GE Healthcare
Harry Solomon
GE Healthcare
Harry Solomon
GE Healthcare
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 215 March 2003
V3 Ballot Submission/Resolution Form
Harry Solomon
GE Healthcare
Harry Solomon
GE Healthcare
Harry Solomon
GE Healthcare
Harry Solomon
GE Healthcare
Harry Solomon
GE Healthcare
Harry Solomon
GE Healthcare
Harry Solomon
GE Healthcare
Harry Solomon
GE Healthcare
Harry Solomon
GE Healthcare
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 216 March 2003
V3 Ballot Submission/Resolution Form
Harry Solomon
GE Healthcare
Harry Solomon
GE Healthcare
JON HENDRICH SONOSITE, INC.
Keith W. Boone
GE Healthcare
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 217 March 2003
V3 Ballot Submission/Resolution Form
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 218 March 2003
V3 Ballot Submission/Resolution Form
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 219 March 2003
V3 Ballot Submission/Resolution Form
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 220 March 2003
V3 Ballot Submission/Resolution Form
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 221 March 2003
V3 Ballot Submission/Resolution Form
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 222 March 2003
V3 Ballot Submission/Resolution Form
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 223 March 2003
V3 Ballot Submission/Resolution Form
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 224 March 2003
V3 Ballot Submission/Resolution Form
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 225 March 2003
V3 Ballot Submission/Resolution Form
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 226 March 2003
V3 Ballot Submission/Resolution Form
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Keith W. Boone
GE Healthcare
Kent Stevenson
Evolvent
Technologies
Kent Stevenson
Evolvent
Technologies
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 227 March 2003
V3 Ballot Submission/Resolution Form
Evolvent
Kent Stevenson
Technologies
Kent Stevenson
Evolvent
Technologies
Evolvent
Kent Stevenson
Technologies
Kent Stevenson
Evolvent
Technologies
Kent Stevenson Evolvent
Technologies
Kent Stevenson
Evolvent
Technologies
Kent Stevenson
Evolvent
Technologies
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 228 March 2003
V3 Ballot Submission/Resolution Form
Kent Stevenson
Evolvent
Technologies
Kent Stevenson
Evolvent
Technologies
Kent Stevenson
Evolvent
Technologies
Kent Stevenson
Evolvent
Technologies
Kent Stevenson
Evolvent
Technologies
Kent Stevenson
Evolvent
Technologies
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 229 March 2003
V3 Ballot Submission/Resolution Form
Kent Stevenson
Evolvent
Technologies
Kent Stevenson
Evolvent
Technologies
Kent Stevenson
Evolvent
Technologies
Kent Stevenson
Evolvent
Technologies
Kent Stevenson Evolvent
Technologies
Kent Stevenson Evolvent
Technologies
Kent Stevenson
Evolvent
Technologies
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 230 March 2003
V3 Ballot Submission/Resolution Form
Kent Stevenson
Evolvent
Technologies
Kent Stevenson
Evolvent
Technologies
Kent Stevenson
Evolvent
Technologies
Kent Stevenson
Evolvent
Technologies
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 231 March 2003
V3 Ballot Submission/Resolution Form
Kent Stevenson
Evolvent
Technologies
Lisa R. Nelson
Lisa R. Nelson
Lisa R. Nelson
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 232 March 2003
V3 Ballot Submission/Resolution Form
Lisa R. Nelson
Lisa R. Nelson
Lisa R. Nelson
Lisa R. Nelson
Randy Levin
FDA
Randy Levin
FDA
Randy Levin
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 233 March 2003
V3 Ballot Submission/Resolution Form
Randy Levin
Randy Levin
FDA
Randy Levin
FDA
Randy Levin
FDA
Randy Levin
FDA
Randy Levin
FDA
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 234 March 2003
V3 Ballot Submission/Resolution Form
Randy Levin
FDA
Randy Levin
FDA
Randy Levin
FDA
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 235 March 2003
V3 Ballot Submission/Resolution Form
Randy Levin
FDA
Randy Levin
FDA
Randy Levin
FDA
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 236 March 2003
V3 Ballot Submission/Resolution Form
Randy Levin
FDA
Ryan W. Murphy
Ryan W. Murphy
Ryan W. Murphy
Ryan W. Murphy
Ryan W. Murphy
Ryan W. Murphy
Ryan W. Murphy
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 237 March 2003
V3 Ballot Submission/Resolution Form
Ryan W. Murphy
Ryan W. Murphy
Ryan W. Murphy
Ryan W. Murphy
Ryan W. Murphy
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 238 March 2003
V3 Ballot Submission/Resolution Form
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 239 March 2003
V3 Ballot Submission/Resolution Form
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande Social Security
Administration
Shanks Kande Social Security
Administration
Shanks Kande Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 240 March 2003
V3 Ballot Submission/Resolution Form
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 241 March 2003
V3 Ballot Submission/Resolution Form
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande Social Security
Administration
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 242 March 2003
V3 Ballot Submission/Resolution Form
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 243 March 2003
V3 Ballot Submission/Resolution Form
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Shanks Kande
Social Security
Administration
Walter Suarez
Kaiser Permanente
Walter Suarez Scott M Robertson
Kaiser Permanente
Walter Suarez Scott M Robertson
Kaiser Permanente
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 244 March 2003
V3 Ballot Submission/Resolution Form
Walter Suarez Scott M Robertson
Kaiser Permanente
Walter Suarez Scott M Robertson
Kaiser Permanente
Bob Yencha
Lantana Group
Bob Yencha
Lantana Group
Bob Yencha
Lantana Group
Bob Yencha
Lantana Group
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 245 March 2003
V3 Ballot Submission/Resolution Form
Bob Yencha
Lantana Group
Bob Yencha
Lantana Group
Bob Yencha
Lantana Group
Bob Yencha
Lantana Group
Bob Yencha
Lantana Group
Bob Yencha
Lantana Group
Bob Yencha
Lantana Group
Bob Yencha
Lantana Group
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 246 March 2003
V3 Ballot Submission/Resolution Form
Bob Yencha
Lantana Group
Bob Yencha
Lantana Group
Bob Yencha
Lantana Group
Jingdong Li
Lantana
Consulting Group
Jingdong Li
Lantana
Consulting Group
Jingdong Li
Lantana
Consulting Group
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 247 March 2003
V3 Ballot Submission/Resolution Form
Jingdong Li
Lantana
Consulting Group
Kate Hamilton Lantana
Consulting Group
Kate Hamilton Lantana
Consulting Group
Kate Hamilton
Lantana
Consulting Group
Kate Hamilton
Lantana
Consulting Group
Kate Hamilton
Lantana
Consulting Group
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 248 March 2003
V3 Ballot Submission/Resolution Form
Kate Hamilton
Lantana
Consulting Group
Kate Hamilton
Lantana
Consulting Group
Kate Hamilton
Lantana
Consulting Group
Kate Hamilton
Lantana
Consulting Group
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 249 March 2003
V3 Ballot Submission/Resolution Form
Kate Hamilton
Lantana
Consulting Group
Kate Hamilton
Lantana
Consulting Group
Kate Hamilton Lantana
Consulting Group
Kate Hamilton
Lantana
Consulting Group
Kate Hamilton
Lantana
Consulting Group
Kate Hamilton Lantana
Consulting Group
Kate Hamilton
Lantana
Consulting Group
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 250 March 2003
V3 Ballot Submission/Resolution Form
Kate Hamilton
Lantana
Consulting Group
Kate Hamilton Lantana
Consulting Group
Kate Hamilton
Lantana
Consulting Group
Kate Hamilton
Lantana
Consulting Group
Kate Hamilton
Lantana
Consulting Group
Kate Hamilton Lantana
Consulting Group
Kate Hamilton Lantana
Consulting Group
Kate Hamilton
Lantana
Consulting Group
Kate Hamilton Lantana
Consulting Group
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 251 March 2003
V3 Ballot Submission/Resolution Form
Kate Hamilton
Lantana
Consulting Group
Kate Hamilton
Lantana
Consulting Group
Kate Hamilton
Lantana
Consulting Group
Kate Hamilton Lantana
Consulting Group
Kate Hamilton
Lantana
Consulting Group
Kate Hamilton
Lantana
Consulting Group
Kate Hamilton Lantana
Consulting Group
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 252 March 2003
V3 Ballot Submission/Resolution Form
Kate Hamilton Lantana
Consulting Group
Kate Hamilton
Lantana
Consulting Group
Brett Marquard Rick Geimer
Brett Marquard
Brett Marquard
Brett Marquard
Gaye Dolin
Lantana
Consulting Group
Gaye Dolin
Lantana
Consulting Group
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 253 March 2003
V3 Ballot Submission/Resolution Form
Gaye Dolin Lantana
Consulting Group
Gaye Dolin
Lantana
Consulting Group
Gaye Dolin
Lantana
Consulting Group
Gaye Dolin Lantana
Consulting Group
Gaye Dolin
Lantana
Consulting Group
Gaye Dolin
Lantana
Consulting Group
Gaye Dolin Lantana
Consulting Group
Gaye Dolin
Lantana
Consulting Group
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 254 March 2003
V3 Ballot Submission/Resolution Form
Gaye Dolin
Lantana
Consulting Group
Gaye Dolin Lantana
Consulting Group
Gaye Dolin
Lantana
Consulting Group
Gaye Dolin
Lantana
Consulting Group
Gaye Dolin Lantana
Consulting Group
Gaye Dolin
Lantana
Consulting Group
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 255 March 2003
V3 Ballot Submission/Resolution Form
Gaye Dolin
Lantana
Consulting Group
Gaye Dolin
Lantana
Consulting Group
Gaye Dolin
Lantana
Consulting Group
Gaye Dolin
Lantana
Consulting Group
Gaye Dolin Lantana
Consulting Group
Gaye Dolin
Lantana
Consulting Group
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 256 March 2003
V3 Ballot Submission/Resolution Form
Gaye Dolin
Lantana
Consulting Group
Gaye Dolin Lantana
Consulting Group
Gaye Dolin
Lantana
Consulting Group
Gaye Dolin
Lantana
Consulting Group
Gaye Dolin
Lantana
Consulting Group
Gaye Dolin
Lantana
Consulting Group
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 257 March 2003
V3 Ballot Submission/Resolution Form
Gaye Dolin
Lantana
Consulting Group
Gaye Dolin Lantana
Consulting Group
Gaye Dolin
Lantana
Consulting Group
Gaye Dolin
Lantana
Consulting Group
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 258 March 2003
V3 Ballot Submission/Resolution Form
Gaye Dolin
Lantana
Consulting Group
Gaye Dolin Lantana
Consulting Group
Brett Marquard
Brett Marquard
Brett Marquard
Brett Marquard
Brett Marquard
Brett Marquard
Brett Marquard
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 259 March 2003
V3 Ballot Submission/Resolution Form
Brett Marquard
Chris Melo
Philips Healthcare
Chris Melo
Philips Healthcare
Chris Melo
Philips Healthcare
Chris Melo
Philips Healthcare
Chris Melo
Philips Healthcare
Corey Spears
McKesson
Corporation
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 260 March 2003
V3 Ballot Submission/Resolution Form
Corey Spears
McKesson
Corporation
Corey Spears
McKesson
Corporation
Corey Spears
McKesson
Corporation
Corey Spears
McKesson
Corporation
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 261 March 2003
V3 Ballot Submission/Resolution Form
Corey Spears
McKesson
Corporation
Corey Spears
McKesson
Corporation
Corey Spears
McKesson
Corporation
Corey Spears
McKesson
Corporation
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 262 March 2003
V3 Ballot Submission/Resolution Form
Corey Spears
McKesson
Corporation
Corey Spears
McKesson
Corporation
Corey Spears McKesson
Corporation
Corey Spears
McKesson
Corporation
Corey Spears
McKesson
Corporation
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 263 March 2003
V3 Ballot Submission/Resolution Form
Corey Spears
McKesson
Corporation
Corey Spears
McKesson
Corporation
Corey Spears
McKesson
Corporation
Corey Spears
McKesson
Corporation
Corey Spears
McKesson
Corporation
Corey Spears
McKesson
Corporation
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 264 March 2003
V3 Ballot Submission/Resolution Form
Corey Spears
McKesson
Corporation
Corey Spears
McKesson
Corporation
Corey Spears
McKesson
Corporation
Corey Spears
McKesson
Corporation
Corey Spears
McKesson
Corporation
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.xls [Ballot] 265 March 2003
V3 Ballot Submission/Resolution Form
Corey Spears
McKesson
Corporation
Corey Spears
McKesson
Corporation
Corey Spears McKesson
Corporation
Corey Spears
McKesson
Corporation
Corey Spears
McKesson
Corporation
Corey Spears
McKesson
Corporation
Corey Spears McKesson
Corporation
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Corporation
Corey Spears
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Corporation
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Corporation
Corey Spears McKesson
Corporation
Corey Spears
McKesson
Corporation
Corey Spears
McKesson
Corporation
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Corey Spears
McKesson
Corporation
Corey Spears
McKesson
Corporation
Corey Spears
McKesson
Corporation
Corey Spears
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Corporation
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Corey Spears
McKesson
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McKesson
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Corporation
Corey Spears
McKesson
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McKesson
Corporation
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McKesson
Corporation
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acking
Received From Notes
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Ballot Submission/Resolution Instructions
Return to Ballot
How to Use this Spreadsheet
Submitting a ballot:
SUBMITTER WORKSHEET:
Please complete the Submitter worksheet noting your overall ballot vote. Please note if you have any negative line items, the ballot is considered
negative overall. For Organization and Benefactor members, the designated contact must be one of your registered voters to conform with
ANSI guidelines.
BALLOT WORKSHEET:
Please complete all lavender columns as described below - columns in turquoise are for the committees to complete when reviewing ballot
comments.
Several columns utilize drop-down lists of valid values, denoted by a down-arrow to the right of the cell. Some columns utilize a filter which
appears as a drop down in the gray row directly below the column header row.
If you need to add a row, please do so near the bottom of the rows provided.
If you encounter issues with the spreadsheet, please contact Karen VanHentenryck (karenvan@hl7.org) at HL7 Headquarters.
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.
55e7beb1-36c4-4a89-b8f8-a319f05b8a53.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".
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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.
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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.."
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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.
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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.
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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.
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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;
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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.
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int the
econciliation
Comments.
of
st indicate a
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en submitted
more input
t no change
some WG's
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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).
------------------------------------------------------------------
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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
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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.
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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?
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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.
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, 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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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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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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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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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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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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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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omment can be scheduled for discussion.
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