Docstoc
EXCLUSIVE OFFER FOR DOCSTOC USERS
Try the all-new QuickBooks Online for FREE.  No credit card required.

Ballot

Document Sample
Ballot Powered By Docstoc
					                                                              V3 Ballot Submission/Resolution Form

                            BALLOT TITLE:       HL7 Version 3 Domain Analysis Model: Detailed Clinical Models for Medical Devices, Release 1
                                                (V3DAM_DCM4MEDDEV_R1_O1_2010SEP) - 1st Comment Only Ballot


                          BALLOT CYCLE:         SEPTEMBER 2010
                      SUBMITTED BY NAME:        Freida Hall
                     SUBMITTED BY EMAIL:        freida.hall@va.gov
                                                727.519.4607
                     SUBMITTED BY PHONE:
           SUBMITTED BY ORGANIZATION (if        US Department of Veterans Affairs
                             applicable):
                      SUBMISSION DATE:                                                                                                     September 27, 2010
                SUBMITTED BY IDENTIFIER:
                  OVERALL BALLOT VOTE:          Affirmative




  If you submit an overall affirmative vote, please make sure you have not included negative line
                                    items on the Ballot worksheet
                                                Enter Ballot Comments (Line Items)                             Instructions




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Submitter]                                1                                                                          March 2003
                                                              V3 Ballot Submission/Resolution Form

                            BALLOT TITLE:       HL7 Version 3 Domain Analysis Model: Detailed Clinical Models for Medical Devices, Release 1
                                                (V3DAM_DCM4MEDDEV_R1_O1_2010SEP) - 1st Comment Only Ballot


                          BALLOT CYCLE:         SEPTEMBER 2010
                      SUBMITTED BY NAME:        Freida Hall
                     SUBMITTED BY EMAIL:        freida.hall@va.gov
                                                727.519.4607
                     SUBMITTED BY PHONE:
           SUBMITTED BY ORGANIZATION (if        US Department of Veterans Affairs
                             applicable):
                      SUBMISSION DATE:                                                                                                     September 27, 2010
                SUBMITTED BY IDENTIFIER:
                  OVERALL BALLOT VOTE:          Affirmative




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Submitter]                                2                                                                          March 2003
                                                            V3 Ballot Submission/Resolution Form



                                                                             Vote
                                                                             and
Number Ballot WG         Artifact   Artifact ID   Chapter   Section   Pubs   Type Existing Wording                        Proposed Wording
      33                                                    2.1              Neg-Mj 3. Sedate Patient




       34                                                   2.1              Neg-Mj 4. Collect Blood Sample




       36                                                   2.1              Neg-Mj Tube placement




       39                                                   2.1              Neg-Mj 7. + 24. Assess Patient




       40                                                   2.1              Neg-Mj 12. Capture X-Ray image



       41                                                   2.1              Neg-Mj 5. Measure ABG



       42                                                   2.2              Neg-Mi 1. Conduct respiratory assessment &
                                                                                    2. Ensure airway is intact …


       43                                                   2.2              Neg-Mj




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                                    3                                                      March 2003
                                                           V3 Ballot Submission/Resolution Form

       32                                                                A-S     "liberate" from ventilator              "wean"



       52                                                  3.2.a        Neg-Mj



       73 HC Dev                                                         A-Q




       75 HC Dev                                                         A-Q


       27                                        page 15                 A-Q     There will be more than one
                                                                                 response team member, and they
                                                                                 share duties. There are typical duty
                                                                                 assignments among nurse, physician,
                                                                                 and respiratory
                                                                                 therapist: these are not illustrated
                                                                                 here, as the participants may perform
                                                                                 atypical tasks in an emergent
                                                                                 situation.


       60                                                  4.1          Neg-Mj Typical reference range


       61                                                  4.1          Neg-Mj Hemoglobin … influences


       62                                                  4.1          Neg-Mj Gas Type


       18 HC Dev                                           pg. 27       Neg-Mj




       54                                                  3            Neg-Mj NumberOf… (Enumeration)

       55                                                  3.4           A-T     Succinylcholne                          Succinylcholine




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                               4                                                         March 2003
                                                                V3 Ballot Submission/Resolution Form

        2 HC Dev         ??         V3DAM_DC      1.1 Post      Line 8   Yes    A-T     EHR documentation                      Electronic Health Record (EHR)
                                    M4MEDDEV      Conditions
                                    _R1_O1_2010
                                    SEP
        1 HC Dev         ??         V3DAM_DC      2. Clinical   Line 4   Yes    A-T     fulfil                                 fulfill
                                    M4MEDDEV      Workflows
                                    _R1_O1_2010
                                    SEP
       25                                         page 15                       A-T     Furthermore, this specification        therefore this section is important in
                                                                                        organize clinical content              setting a boundaries of the analysis.

       26                                         page 15                       A-Q     Manage Patient on Ventilator




       28                                         Page 16                       A-Q




       35                                                       2.1            Neg-Mj


       37                                                       2.1            Neg-Mj 14. Begin Manual Ventilation




       38                                                       2.1            Neg-Mj 15. Attach ventilator to electricity,
                                                                                      air, and oxygen.


        3 HC Dev         ??         V3DAM_DC      2.2 Manage    Line 5   Yes    A-T     wile                                   while
                                    M4MEDDEV      Patient on
                                    _R1_O1_2010   Ventilator
                                    SEP           Workflow
        6 HC Dev                                  page 6                         A-S    A business use case is a high-level
                                                                                        use case intended to capture the
                                                                                        business requirements of the project
                                                                                        stakeholders. In our case the
                                                                                        business use case is documented
                                                                                        using specific clinical scenarios




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                                      5                                                                               March 2003
                                                                V3 Ballot Submission/Resolution Form

        8 HC Dev                                  page 6                        A-S   Analysis Information Mode          Information Model




       22 HC Dev                                  A. Approach                   A-T   Furthermore, this specification    Furthermore, this specification
                                                  page 4                              organize clinical content          organizes clinical content

       23                                         A. Approach                   A-T   ISO NIWP 13972 with URL            Correct URL is
                                                  page 5                              mistyped as                        http://www.tc215wg3.nhs.uk/docum
                                                                                      http://http/www.tc215wg3.nhs.uk/do ents/isotc215wg3_n464.pdf
                                                                                      cuments/isotc215wg3_n464.pdf

       24                                         A. Approach                   A-S   Detailed Clinical Models
                                                  page 6                              A separate section will contain all
                                                                                      the DCMs identified or reused by
                                                                                      this specification. DCM1 and DCM2
                                                                                      are sample DCM specifications
                                                                                      identified during the analysis
                                                                                      process.
       11 HC Dev                                  page 43                       A-S   "Public" appears under each Value delete Public
                                                                                      term.

        5 HC Dev         ??         V3DAM_DC      Figure 4.2b Title      Yes    A-T   n/a                                n/a
                                    M4MEDDEV      DCMs
                                    _R1_O1_2010   representing
                                    SEP           Ventilator
                                                  Settings


       20                                                       pg. 42         Neg-Mj DCM: ArterialBloodGas




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                                    6                                                                     March 2003
                                                     V3 Ballot Submission/Resolution Form

       59                                            4.1          Neg-Mj PaCO2 in mm Hg



       63                                            4.1          Neg-Mj Gas Exchange Observation Method

       65                                            4.2.a        Neg-Mj




       76 HC Dev                                                   A-C




       77 HC Dev                                                   A-C
       29 HC Dev         ??                                       Neg-Mj Detailed Clinical Model for Medical … for Intubation and Ventilator
                                                                         Devices                             treatment.




       19                                            pg 29        Neg-Mi NumberOfEsophagealIntubations,
                                                                         NumberOfLaryngoscopyAttempts


       45                                            3.1          Neg-Mj vendorId




       46                                            3.1          Neg-Mj modelNumber




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                         7                                                                   March 2003
                                                     V3 Ballot Submission/Resolution Form

       47                                            3.1          Neg-Mj modelNumber - serialNumber




       48                                            3.1          Neg-Mj DeviceParameter - measuringDevice




       50                                            3.2.a        Neg-Mj

       51                                            3.2.a        Neg-Mj


       53                                            3.2          Neg-Mj




       56                                            3.4          Neg-Mj None, Succ., Rocuronium



       57                                            3.4          Neg-Mj Sedation




       58                                            3.4          Neg-Mj Sedation

       72 HC Dev                                                   A-C




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                         8                                 March 2003
                                                              V3 Ballot Submission/Resolution Form

       74 HC Dev                                                               A-C




        4 HC Dev         ??         V3DAM_DC      2.3 Liberate Line 5   Yes    A-T     "to terminate a patient"           to liberate a patient
                                    M4MEDDEV      Patient from
                                    _R1_O1_2010   Ventilator,
                                    SEP           Planned
                                                  (Process)
       66                                                      4.2.a          Neg-Mj vendorId



       67                                                      4.2.a          Neg-Mj modelNumber



       68                                                      4.2.a          Neg-Mj modelNumber - serialNumber


       70                                                      4.2.a           A-C     DeviceParameter


       78 HC Dev                                                               A-Q



       69                                                      4.2.a          Neg-Mj Ventilator mode and waveform




       44                                                      2.3            Neg-Mj


        7 HC Dev                                  page 6                       A-S     The Analysis Information Mode is   The Information Model is an
                                                                                       an element of Domain Analysis      element of Domain Analysis
                                                                                       Model (DAM)                        Package (DAP).

       10 HC Dev                                  page 42                      A-S     ArterialBloodGas                   Arterial Blood Gas




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                                     9                                                                March 2003
                                                           V3 Ballot Submission/Resolution Form

       12 HC Dev                                 page 50                 A-S     Therapeutic Device


       13 HC Dev                                 page 51                 A-S     Ventilator Settings


       14 HC Dev                                 page 55                 A-S     Monitoring Device


       15 HC Dev                                 page 58                 A-S     Consumable Device


       64                                                  4.1          Neg-Mj



       71                                                  4.2          Neg-Mj OCL Contraints




        9 HC Dev                                 page 23                 A-S     Medical Devices General
                                                                                 Requirements

       49                                                  3.1          Neg-Mj Verification



       16 HC Dev                                 page 60                 A-S     Data Types


       17 HC Dev                                                        Neg-Mj There does not appear to b a visable
                                                                               relationship to the RIM.There are
                                                                               many UML models. It should not be
                                                                               called a version 3 model if it does
                                                                               not show RIM or RMIM version




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                             10                                     March 2003
                                                              V3 Ballot Submission/Resolution Form

       30                                                                  Neg-Mj




       31                                                                  Neg-Mj




       79 HC Dev                                                            A-C




                                                 page 24                            device parameter class




                                                 page 27-29                         variable names




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                                11                         March 2003
                                                              V3 Ballot Submission/Resolution Form

                                                 page 27-29                     variable names


                                                 page 27-29                     variable names




                                                 Page 35                        medication administration




                                                 Page 35-36




                                                 Page 36-37



                                                 Page 38-39




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                             12                           March 2003
                                                              V3 Ballot Submission/Resolution Form

                                                 Page 43-44




                                                 Page 43




                                                 Page 43




                                                 Page 43




                                                 Page 43




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                             13                    March 2003
                                                           V3 Ballot Submission/Resolution Form

                                                 Page 43




                                                 Page 55




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                          14                    March 2003
                                                                            V3 Ballot Submission/Resolution Form



                                                                      In person
                                                                      resolution   Comment                                                            Disposition
Comments                                                              requested    grouping        package      Disposition               Withdrawn   Committee
This is optional e.g., in case of unconsciousness. And there                       ask - drafted   21 wf        Persuasive
should probably be a distinction between pre-medication
sedation, induction of anesthesia and muscle relaxation.


This is optional in case of emergency and obvious respiratory                      ask - drafted   21 wf        Persuasive
failure.



Confirmation by primary and secondary methods should be put                        ask - drafted   21 wf        Persuasive with mod
into one step. There are also other signs (condensation on tube)
that are not mentioned. In practice that would all go together.



You will surely watch your patient all the time, not sure why                      ask - drafted   21 wf        Persuasive
these 2 steps are specifically shown. I'd argue that unless in
emergency you would hopefully have at least your pulse
oximeter, and probably also blood pressure and EKG monitor
attached before you start intubating.
Still puzzled by the prominence of this step. I see this only as a                 ask             21 wf        Not persuasive with mod
later assessment that you might do some hours (or days) after
initial intubation, but certainly not immediately to confirm
placement.
Wouldn't do that only once at the beginning. Pulse oximeter                        ask - drafted   21 wf        Persuasive with mod
monitoring. ABG might be done also, in many cases the ABG is
a diagnostic step leading to the decision to intubate, not
something you do because you intubate.
Aren't these both part of the same activity? It is multiple aspects                ask             22 wf        Not persuasive with mod
of the same step.


I don't like this flow-chart modeling. Too simplistic and                          ask - drafted   22 wf        Not persuasive with mod
sequential. E.g., 2 and 7 are so far apart when they might be
done as part of the same step. Same with 7 and 9; and with 3.
and 10. The sequencing is not necessarily natural or reasonable.
11, 12 and 13 is also unnecessarily sequenced.




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                                                         15                                                       March 2003
                                                                    V3 Ballot Submission/Resolution Form

I believe "weaning" is the more common term used in English              ask - drafted   23 wf        Persuasive with mod
(Google test: 357k over 71k)


The model is insufficient since you may change the tubus and             ask - drafted   infoModel    Persuasive with mod
intubation method during the process. This is another argument
against this flat summary reporting. See previous point.

 pg 25&26: Intubation clinical note class 3.2a & 3.2b shouldn't          ask - drafted   infoModel    Persuasive
these include documentation of the initial ETT level @ lip or
nose which should be documented and assessed routinely to
determine if the ETT placement has not changed since insertion

 pg 29 &31: Number of EsophagealIntubations- Define this; is             ask - drafted   infoModel    Persuasive
it the # of ETTs used during this intubation or # of ETT
intubations during this hosp stay?
Page 7 has Use Case Actors:Response Team Members = nurse,                cfu             20 wf        Considered for future use
physician, Respiratory therapist - are these only examples? Why
is there an enumeration of ProcedureStaffJobTitle (page 39) that
is not linked to "PriviledgeIntubator" on page 16 as a coded
type for Clinician on page 23 in the Medical Device Analysis?
Provider code - e.g., NUCC Provider Taxonomy codes, are
likely important information for Quality measures (see
eMeasures which includes LicensedRole and QualifiedRole
types) etc. and difficult to ascertain with only ID, which might
run across more than one clinician role.

is that part of the model? A constraint? Doesn't belong here like        Discuss         dcm          Persuasive with mod
this. Or should be done as a RIM Act definition structure.

That is an incorrect UML association role name, and the class            Discuss -       dcm          Persuasive
has nothing and what does the association associate? Other               drafted
properties influence the saturation too.
This is too clever one-off modeling with saturation. It's just an        Discuss -       dcm          Persuasive
observation, make a list of the LOINC codes to be used and be            drafted
done with it.
Cormack Lehane Scale, number of esophageal intubations, etc              Discuss -       infoModel    Persuasive
are clinical observations that need universal identifiers.               drafted
Recommend the use of LOINC to provide codes for such
variables.


A number is a number, not an enumeration type with values 0,             Discuss -       infoModel    Persuasive
1, and 2. What if I have 3 or 4 failed intubations?                      drafted
                                                                         done            infoModel    Persuasive




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                                               16                               March 2003
                                                                           V3 Ballot Submission/Resolution Form

Spell first citation of acronym and abbreviate all subsequent         No        done        11 uc        Persuasive
references


Spelling                                                              No        done        20 wf        Persuasive



                                                                                done        20 wf        Persuasive


Why is Liberate Patient "planned" but Manage Patient is not?                    Discuss -   20 wf        Persuasive with mod
                                                                                drafted




act 2.1 - Lab tech is in the workflow for unplanned intubate                    done        20 wf        Persuasive
patient but not included as a clinician in the uc.1 use case actors
- unclear why.


So many detailed steps mentioned, but provisional respiratory                   ask         21 wf        Persuasive with mod
support with mask and bag is not mentioned at all??

I sure hope you don't wait for an X-Ray before you do that! This                done        21 wf        Persuasive
step is set far too late. In reality you do bag and mask before
intubation, will bag right after tube is blocked to even assess
placement.

Again far too late. Except for emergency situations you would                   done        21 wf        Persuasive
hopefully have your equipment ready and started before you
intubate. That whole pathway from 15 to 19 should be prepared
in advance or in parallel.
Spelling                                                      No                done        22 wf        Persuasive



"high-level" and "specific clinical scenarios" seem                             done        approach     Persuasive with mod
contradictory.




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                                                  17                         March 2003
                                                                  V3 Ballot Submission/Resolution Form

I suggest dropping the term "Analysis" since there is only one         done         approach   Persuasive with mod
information model in the package




                                                                       done         approach   Persuasive


                                                                       done         approach   Persuasive




This is not a definition. Please add as this is an important           done         approach   Persuasive with mod
concept in this DAM.




                                                                       Production   dcm        Persuasive


Top package is obstructing the title                                   Production   dcm        Persuasive




The modeling of the measurement variables seems disconnected           done         dcm        Persuasive with mod
from how they are recorded in the EHR (as observable entities).
In most cases I think you would want to have the explicit blood
gas results in the record, which could be retrieved
automatically: e.g. LOINC codes 2703-7 Oxygen [Partial
pressure] in Arterial blood, 2019-8 Carbon dioxide [Partial
pressure] in Arterial blood, etc.




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                                        18                         March 2003
                                                                       V3 Ballot Submission/Resolution Form

I've seen it in Pa also. The unit should not be fixed at this level.        done      dcm           Persuasive



missing pulse-oximeter                                                      drafted   dcm           Persuasive

This should be the Common Product Model or at least have a                  done      dcm           Persuasive with mod
relationship with it.



 pg 55 Class 4.3.a medical device general requirements & pg 58              done      dcm           Persuasive with mod
Class 4.4 consumable medical device: - add SPLr5 UDI
characteristic>> labeler, trade/brand/proprietary name, sterile
status, number of times usable



pg 59- define consumable device                                             drafted   dcm           Persuasive
The title is confusing. Sounds like it wants to model the devices           discuss   file, intro   Persuasive with mod
(things) but really the content describes clinical activity that
may or may not involve certain devices.




Recommend modeling these as numerics (not ordinal scale) -                  done      infoModel     Persuasive
the raw count could always be transformed.


The "Vendor" certainly should be a class, not just some id                  done      infoModel     Persuasive with mod
foreign key. But what does "vendor" mean after all? The
labeler? The OEM manufacturer? The retailer? The
manufacturing plant?

Many devices have multiple model numbers, catalog numbers,                  done      infoModel     Persuasive with mod
etc. But there is also such as thing as a trade item id, more
controlled, in the U.S. and GHTF the Unique Device Identifier
(UDI).




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                                           19                           March 2003
                                                                  V3 Ballot Submission/Resolution Form

In fact you have here 2 classes, the Device Kind and the Device        done      infoModel   Persuasive with mod
Instance. There may also be a Device Lot invetween, especially
for supply type devices (tubes).


There are 2 things confused here. There are parameter settings,        done      infoModel   Persuasive
and parameter verification observations. And there is a device
whose operation is monitored and the measuring device by
which such monitoring is performed. They may be different.
For instance, you have the ventilator tidal volume setting, the
actual volume delivered, the ventilator's volume management
system, but then you also have the volumeter to measure the
volume. All different.

Scale cutoffs such as "GT 3" should be avoided.                        done      infoModel   Persuasive

Derivative count reportings should be avoided. Ideally every           done      infoModel   Persuasive with mod
intubation attempt should be one Act and consists of
Laryngoscopy and Intubation.
The procedure details and documentation should have the same           done      infoModel   Persuasive with mod
structure as the procedure. If modeled using RIM Acts it would
come out naturally the same. But by your refusal to use the RIM
for describing the process you end up with 3 models that have
no visible relationship: the workflow 2.1, 3.2a the process
details, and the documentation 3.2b.

You certainly can have other relaxants, Pancuronium,                   drafted   infoModel   Persuasive with mod
Vecuronium, … This should not be an "Enumeration", it is a
medicinal product and should again use parts of the common
product model.
Same comment, you don't have an enumeration but a product              done      infoModel   Persuasive with mod
and use the common product model.



Missing N2O and in that case your dose is not in mg.                   drafted   infoModel   Persuasive

 pg 24: Class 3.1: Medical device analysis; Device class               done      infoModel   Persuasive with mod
attributes- add Structured Product Labeling Release 5 (SPLr5)
Unique Device Identification characteristic>> labeler,
trade/brand/proprietary name




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                                    20                           March 2003
                                                                     V3 Ballot Submission/Resolution Form

 pg. 26: class 3.2b Consumable Medical Device: ETT- add                   done        infoModel    Persuasive with mod
SPLr5 UDI characteristic>> labeler, trade/brand/proprietary
name, sterile status, number of times usable



More appropriate reference IAW paragraph header; "terminate" No           done        23 wf        Persuasive
can have negative healthcare connotation



As above: The "Vendor" certainly should be a class, not just              duplicate   dcm          Persuasive with mod
some id foreign key. But what does "vendor" mean after all?
The labeler? The OEM manufacturer? The retailer? The
manufacturing plant?
As above: Many devices have multiple model numbers, catalog               duplicate   dcm          Persuasive with mod
numbers, etc. But there is also such as thing as a trade item id,
more controlled, in the U.S. and GHTF the Unique Device
Identifier (UDI).
As above: In fact you have here 2 classes, the Device Kind and            duplicate   dcm          Persuasive with mod
the Device Instance. There may also be a Device Lot invetween,
especially for supply type devices (tubes).
The parameters are almost all Observation Goals (except                   future      dcm          Considered for future use
perhaps Tidal Volume which would be expected at times to
overflow through pressure valve.)
could you consider adding a use case for when the ventilator              future                   Considered for future use
has malfunctioned and needs to be changed out? The FDA is
looking at using this for reporting adverse events.

Ventilator mode and waveform could be just thought of as                  future /    dcm          Considered for future use
kinds of parameters. I like that you don't do it that way. But you        discuss
should realize that there is a difference between the Ventilator
Device and the Ventilation Action that it delivers. Hence the
CPM has a DeviceAct. The "mode/waveform" thing is then the
DeviceAct.code.
The weaning process is far to simplistic. You may have days of            ignore      23 wf        Not related
training, CPAP, etc. It just isn't that uniform and simple.

The term Domain Analyis Model is confusing since it contains              ignore      approach     Not persuasive
another model (Analysis Information Model) and other items
like a Glossary. Instead, I recommend the term "Domain
Analysis Package".
technical representation instead of clinician friendly.                   ignore      dcm          Not persuasive




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                                            21                               March 2003
                                                                    V3 Ballot Submission/Resolution Form

equipment-centric rather than clinician-centric.                         ignore   dcm          Not persuasive


technical. Not clinician-friendly.                                       ignore   dcm          Not persuasive


technical. Not clinician-friendly.                                       ignore   dcm          Not persuasive


technical. Not clinician-friendly.                                       ignore   dcm          Not persuasive


I pretty much object to the modeling style of this entire model.         ignore   dcm          Not related
It is too "clever" (with "influences" relations) and one-off but
internally inconsistent (e.g., Variable on the one hand and
Carbon Dioxide Saturation on the other.)
I do not like the way this is done with UML and OCL                      ignore   dcm          Not related
constraints. It could be so much easier if this was all expressed
immediately through HL7 RIM Observation definition
structures. There you would give the LOINC code, a range with
unit, much more simple that way as the RIM Observation
definition structures would be simply a prototype of the actual
reporting structure: just change the moodCode to EVN fill in
the time and the actual values and be done.

Seek more review                                                         ignore   infoModel    Not related


An odd modeling. Verification is an Observation Event. The               ignore   infoModel    Not persuasive
DeviceParameter is often an Observation Goal. The RIM style
would be much more correct, this model here is confused and
incomplete.
These datatypes are not specific to medical devices.                     ignore   types        Not persuasive


                                                                         ignore                Not persuasive




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                                        22                    March 2003
                                                                     V3 Ballot Submission/Resolution Form

Please clarify relationship to the Common Product Model which             ignore           Not persuasive
should be the one and only model to describe the devices
themselves.




A comment I have to all the DCMs being brought forward by                 ignore           Not persuasive
our dutch friends: I note that all visible relationship to the HL7
RIM have been removed. In earlier versions these existed, then
the models where actually little RMIMs. I liked that. Now they
are other UML models and I am concerned about unnecessary
problems introduced by not using the RIM and other
established RMIMs (such as the common product model) for
showing the details of the DCMs. More detail comments will
appear below.



Assuming that the main purpose of this ballot was the collection          ignore           Referred and tracked
of comments from a wider community, I cast my vote
affirmative. The discussions following this ballot should focus
on developing and explaining the methodology for creating
DAMs/DCMs as a source for modeling of more specific
"platform-specific" models. I would expect that the comments
submitted will be addressed with this in mind: The objectives of
the next project steps should be defined before addressing the
ballot comments in too much detail.

                                                                                           Persuasive with mod
It would be best if this was explicitly modeled to include
more of the attributes contained in other clinical
observations - to allow attributes such as normal ranges,
abnormal flags, reporting time and other attributes.
Also would be helpful to indicate that these will be LOINC
codes in most cases and give a link to LOINC.
The items such as Cormach Lehane Scale, endotrachial                                       Considered for future use
intubation site, instrumentation, number of esophageal
intubations, etc. All look like clinical variables or questions
that will need codes to me. These would be easy to define
as LOINC variables with the answer lists tied to them, ala
the Glasgow coma scores, the survey instruments and
the vital signs now carried in LOINC.




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                                    23                               March 2003
                                                             V3 Ballot Submission/Resolution Form

Would suggest making the fields that count the number of                           Persuasive
tried attempts, numeric fields, where the value is the
number of attempts.
 The value for the patient location answers should                                 Considered for future use
probably be taken from a larger more standardized list.
NICU would be one more ICU to include for sure.


 Why not just reference the standard medication data                               Considered for future use
structure from HL7.
 One might also argue that you don’t need to model the
medication administration class as a data structure
because it could be inferred from the medication list and
knowledge bases about medications. The same would be
true of the other special medication classes below. Then
this becomes a query instead of an additional data
structure to maintain




                                                                                   Considered for future use
If on the other hand you conceived of providers explicitly
stating the name of the neuromuscular blockade they
used- then you might consider a variable with an answer
list. That seems to be your intention. (But the former
require less manual entry and should be more reliable)
This same statement could apply to the other medication
class variables.

 These pages contain more variables that could be                                  Considered for future use
defined as explicit observations (LOINC codes) with pre
defined data types and answer lists. Could be reused for
many other purposes.
                                                                                   Considered for future use




Think the provider attributes are being defined in many
other HL7 contexts (related to privileging) and could be
borrowed from them.




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                            24                               March 2003
                                                                V3 Ballot Submission/Resolution Form

                                                                                      Considered for future use
Detailed clinical models
The purpose is not clear-
Is this a knowledge base or something that relates to a
particular patient?
If it is patient specific many of these variables- e.g. units
of measure and reference range are stored in each
instance of the patient record and can vary by lab and by
patient (the normal range for hemoglobin is different in
males and females)
If it is a more general purpose, the observation master file
that all medical record systems have, contains the normal
range and units of measure-for each observation; so no
need to specialize that part of the model just for blood
gases. The master file for variables would also carry
information about panels and the children they contain.

What you may want is an influence diagram relating the
variables and how they influence each other
physiologically. That structure would not have to carry the
detail that is either carried in the patient record or the
master variable file.
You have modeled the attributes of interest as SNOMED                                 Considered for future use
codes- which might be right in some cases if thought
about as facts in a dictionary. When you deal with
patient variables would think you would want to use the
same codes as those that carry those variables in the
patient record (The questions), in which case Body
temperature would be LOINC codes.
 8310-5 Body temperature
  Which takes a numeric value?
 11449-6 Pregnancy status - Reported
 Which is a categorical variable?
30525-0 Age
 Would think you would want to report the explicit blood
gas results that influenced the decision - not describe
them- because the results can be pulled automatically
and tied to the decision without users having to make
judgments and do (much) data entry.
By the way, the UOM for base excess is mmol/L (or                                     Persuasive with mod
meq/L which means the same thing)




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                               25                               March 2003
                                                              V3 Ballot Submission/Resolution Form

                                                                                    Persuasive
The modeling of blood gases is going in the wrong
direction. (P 46) The measurement and interpretation of
PO2 and PCO2 are as different as height and weight.
These should be separated
aPO2 is LOINC # 2703-7 Oxygen [Partial pressure] in
Arterial blood
 APCO2 is LOINC #2019-8 Carbon dioxide [Partial
pressure] in Arterial blood


Similar comments as to the blood gas model regarding
clarifying the goal. And whether one needs to particularize
some attributes to the instruments or tie them to the
master file of observations. Then keep only the attributes
that tie to the instruments alone with the instruments.




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                             26                    March 2003
                                                                      V3 Ballot Submission/Resolution Form




                                                                          Against


                                                                                        Abstain
                                                                                                  Change    Substantive                                                   On Behalf of




                                                                For
Disposition Comment                    Responsible Person                                         Applied   Change        Submitted By      Organization   On behalf of   Email
We need to identify required vs.                            6         0             0
optional preconditions.
We will detail clinical information to                                                                                    Gunther Schadow
the level necessary to support device                                                                                                       Regenstrief
interoperability.                                                                                                                           Institute
We need to identify required vs.       removed              6         0             0
optional preconditions.
We will detail clinical information to                                                                                    Gunther Schadow
the level necessary to support device                                                                                                       Regenstrief
interoperability.                                                                                                                           Institute
We will ask SMEs whether we                                 6         0             0
should add "condensation on tube"
as a form of confirmation.
                                                                                                                          Gunther Schadow
We will detail clinical information to
the level necessary to support device                                                                                                       Regenstrief
interoperability.                                                                                                                           Institute
We need to consult the clinicians to removed                6         0             0
validate the sequence.
                                                                                                                          Gunther Schadow
                                                                                                                                            Regenstrief
                                                                                                                                            Institute
We need to consult the clinicians to                        6         0             0
validate the sequence.
                                                                                                                          Gunther Schadow
                                                                                                                                            Regenstrief
                                                                                                                                            Institute
We need to consult the clinicians to removed                6         0             0
validate the sequence.
                                                                                                                          Gunther Schadow
                                                                                                                                            Regenstrief
                                                                                                                                            Institute
We need to add more documentation                           6         0             0
to make sure whether these steps are
                                                                                                                          Gunther Schadow
indeed two steps or two aspects.                                                                                                            Regenstrief
                                                                                                                                            Institute
We need to consult the clinicians to                        6         0             0
validate the sequence.
Workflow may vary: we are working
                                                                                                                          Gunther Schadow
on ways to accommodate variability
and still support functional                                                                                                                Regenstrief
specifications.                                                                                                                             Institute




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                                                          27                                                                       March 2003
                                                                           V3 Ballot Submission/Resolution Form

"Liberate" includes "ventilator          currently using Goldman &
weaning" and extubation. "Wean           Karpinsky terms
                                                                                                      Gunther Schadow
and extubate" may be better used                                                                                        Regenstrief
here.                                                                                                                   Institute
We will refactor this class.                                          6    0   0
                                                                                                      Gunther Schadow
                                                                                                                        Regenstrief
                                                                                                                        Institute
We need to consult the clinicians to in info model; already
validate the sequence.               noted in flow
                                                                                                      Randy Levin

                                                                                                                        FDA
We need to consult the clinicians to
validate the sequence.                                                                                Randy Levin
                                                                                                                        FDA
Right now the emphasis is not on
defining job roles but we should
consider using the provider
taxonomy if those requirements
arise.
                                                                                                      Kathleen Connor




                                                                                                                        Microsoft
We need to capture the reference         suggest protocol construct   6    0   0
range, but are still deciding on the                                                                  Gunther Schadow Regenstrief
appropriate format for doing so.                                                                                      Institute
We need to refactor these classes.       removed                      6    0   0
                                                                                                      Gunther Schadow Regenstrief
                                                                                                                      Institute
We should have a consistent style                                     6    0   0
for referring to coded information.                                                                   Gunther Schadow Regenstrief
                                                                                                                      Institute
We will use a LOINC as example                                        12   1   2
value set in place of the current
enumeration using the best matching
                                                                                                      Daniel Vreeman
code. If a code does not exist we will
include a description of the concept.                                                                                 Regenstrief
                                                                                                                      Institute
Use a numeric data type.                                              6    0   0                                      Regenstrief
                                                                                                      Gunther Schadow
                                                                                                                      Institute
Fix typo.                                Jay Lyle                     6    0   0    Yes                               Regenstrief
                                                                                                      Gunther Schadow
                                                                                                                      Institute




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                                          28                                        March 2003
                                                                            V3 Ballot Submission/Resolution Form

Add citation                             Jay Lyle                                    Yes
                                                                                                       Freida Hall                                           Greg.Staudenmaier@va.gov
                                                                                                                                            Staudenmaier, Greg
                                                                                                                         US Department of
                                                                                                                         Veterans Affairs
Fix spelling                             Jay Lyle                                    Yes
                                                                                                       Freida Hall                                           Greg.Staudenmaier@va.gov
                                                                                                                                            Staudenmaier, Greg
                                                                                                                         US Department of
                                                                                                                         Veterans Affairs
Fix wording                              Jay Lyle                                    Yes
                                                                                                       Kathleen Connor
                                                                                                                         Microsoft
We will clarify that a planned           Both intubation and
intubation performed as a part of a      extubation can be planned
procedure is different from an ad-       or unplanned. Management
                                                                                                       Kathleen Connor
hoc intubation intervention.             is not currently partitioned
                                         in that way.
                                                                                                                         Microsoft
We need make sure the actors         Jay Lyle                                        Yes
referenced in the activity diagrams
are identified in the use case                                                                         Kathleen Connor
description and associated diagrams.
                                                                                                                         Microsoft
It is already mentioned but not clear,                                  6   0   0
perhaps.                                                                                               Gunther Schadow Regenstrief
                                                                                                                       Institute
We will change this.                  Jay Lyle                          6   0   0    Yes
JL: This refers to manual ventilation
on ET tube. We will clarify that                                                                       Gunther Schadow
name and add a step to bag the                                                                                           Regenstrief
patient earlier                                                                                                          Institute
We need to consult the clinicians to Jay Lyle                           6   0   0    Yes
validate the sequence.
                                                                                                       Gunther Schadow
                                                                                                                         Regenstrief
                                                                                                                         Institute
Fix spelling                             Jay Lyle                                    Yes
                                                                                                       Freida Hall                                           Greg.Staudenmaier@va.gov
                                                                                                                                            Staudenmaier, Greg
                                                                                                                         US Department of
                                                                                                                         Veterans Affairs
A use case is a collection of specific Jay Lyle                                      Yes
scenarios. We will add this for
clarification.
                                                                                                       Freida Hall                          Luigi Sison

                                                                                                                         US Department of
                                                                                                                         Veterans Affairs




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                                           29                                                                        March 2003
                                                          V3 Ballot Submission/Resolution Form

In HL7 and Information Model       Jay Lyle                        Yes
would be expected to be RIM-based.
The qualifier ensures that we are
clear. We should probably                                                            Freida Hall                          Luigi Sison
emphasize the "analysis" or
"computationally-independent"                                                                          US Department of
aspect of this model.                                                                                  Veterans Affairs
Fix wording                        Jay Lyle                        Yes
                                                                                     Kathleen Connor
                                                                                                       Microsoft
Fix reference.                        Jay Lyle                     Yes

                                                                                     Kathleen Connor

                                                                                                       Microsoft
Add reference to the DCM              Jay Lyle                     Yes
definition.

                                                                                     Kathleen Connor


                                                                                                       Microsoft
We will delete if from the document
after publication.                                                                   Freida Hall       US Department of Luigi Sison
                                                                                                       Veterans Affairs
Fix publication


                                                                                     Freida Hall                                           Greg.Staudenmaier@va.gov
                                                                                                                          Staudenmaier, Greg

                                                                                                       US Department of
                                                                                                       Veterans Affairs
Each observation in the panel must Jay Lyle          12   1   2    Yes
have a coded attribute that
references a correct, example,
standard-based code, it must use
standard-based values and reference
range attributes, and it must data                                                   Daniel Vreeman
types that are consistent. There may
be other ABG tests that we did not
included because they were not
germane.
JL: readings are coded                                                                                 Regenstrief
                                                                                                       Institute




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                         30                                                                        March 2003
                                                                          V3 Ballot Submission/Resolution Form

We need to refactor the observations Jay Lyle                        6    0   0    Yes
consistent with other standards.
                                                                                                     Gunther Schadow
JL: PQ not restricted                                                                                                Regenstrief
                                                                                                                     Institute
We will add.                                                         6    0   0                                      Regenstrief
                                                                                                     Gunther Schadow
JL:No longer enumerated                                                                                              Institute
We will remove these example         Jay Lyle                        6    0   0    Yes
attributes of a devices, used as
context, not an exhaustive labeling                                                                  Gunther Schadow
scheme, in order to avoid confusion.                                                                                   Regenstrief
                                                                                                                       Institute
We will clarify that the device         Jay Lyle                                   Yes
labeling information is here only for
context, not the primary focus' we
will refer the reader to SPLr5 for                                                                   Randy Levin
labeling-specific details since they
are not in scope here.
JL: removed                                                                                                            FDA
                                        removed                                                      Randy Levin       FDA
This model is intended to address a "DAM" doesn't really             12   1   2
variety of use cases. Enumerating       answer the question. I
the use case in the title could         propose we leave it alone.
become unmanageable. The model is
not necessarily limited to those use
case; the use cases included here are                                                                Gunther Schadow
the first identified as a high-priority
to the stakeholders. We will add
"Domain Analysis Model" to the
title to clarify the purpose of the
document.                                                                                                              Regenstrief
                                                                                                                       Institute
We will change the type from coded Jay Lyle                          12   1   2    Yes
to numeric. We should consider
                                                                                                     Daniel Vreeman
whether these attributes relevant to                                                                                   Regenstrief
the procedure at hand.                                                                                                 Institute
We will remove these example         Jay Lyle                        6    0   0    Yes
attributes of a devices, used as
context, not an exhaustive labeling                                                                  Gunther Schadow
scheme, in order to avoid confusion.                                                                                   Regenstrief
                                                                                                                       Institute
We will remove these example         Jay Lyle                        6    0   0    Yes
attributes of a devices, used as
context, not an exhaustive labeling                                                                  Gunther Schadow
scheme, in order to avoid confusion.                                                                                   Regenstrief
                                                                                                                       Institute




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                                         31                                        March 2003
                                                         V3 Ballot Submission/Resolution Form

We will remove these example         Jay Lyle        6   0   0    Yes
attributes of a devices, used as
context, not an exhaustive labeling                                                 Gunther Schadow
scheme, in order to avoid confusion.                                                                  Regenstrief
                                                                                                      Institute
We will clarify the relationship        Jay Lyle     6   0   0    Yes
between the settings, the actual
delivered volume, and
measurements.
                                                                                    Gunther Schadow


                                                                                                    Regenstrief
                                                                                                    Institute
We should replace this with a           Jay Lyle     6   0   0    Yes                               Regenstrief
                                                                                    Gunther Schadow
numeric data type.                                                                                  Institute
We will refactor this class.            Jay Lyle     6   0   0    Yes
                                                                                    Gunther Schadow Regenstrief
                                                                                                    Institute
We will refactor this class.            Jay Lyle     6   0   0    Yes


                                                                                    Gunther Schadow

                                                                                                      Regenstrief
                                                                                                      Institute
Generalize this to relaxant agent and                6   0   0
provide references to relevant drug
                                                                                    Gunther Schadow
codes.                                                                                                Regenstrief
                                                                                                      Institute
This model refers to an administered Jay Lyle        6   0   0    Yes
substance not a product, therefore
we should use the                                                                   Gunther Schadow
SubstanceAdministration for                                                                         Regenstrief
reference.                                                                                          Institute
We need to generalize sedation                       6   0   0                                      Regenstrief
                                                                                    Gunther Schadow
accordingly.                                                                                        Institute
We will remove these example         Jay Lyle        6   0   0    Yes
attributes of a devices, used as
context, not an exhaustive labeling                                                 Randy Levin
scheme, in order to avoid confusion.
                                                                                                      FDA




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                        32                                        March 2003
                                                         V3 Ballot Submission/Resolution Form

We will clarify that the device       Jay Lyle                    Yes
labeling information is here only for
context, not the primary focus' we
                                                                                    Randy Levin
will refer the reader to SPLr5 for
labeling-specific details since they
are not in scope here.                                                                                FDA
Correct ambiguity                     Jay Lyle                    Yes

                                                                                    Freida Hall                                           Greg.Staudenmaier@va.gov
                                                                                                                         Staudenmaier, Greg
                                                                                                      US Department of
                                                                                                      Veterans Affairs
Duplicate of #44                     Jay Lyle        6   0   0    Yes
                                                                                    Gunther Schadow
                                                                                                      Regenstrief
                                                                                                      Institute
Duplicate of #45                     Jay Lyle        6   0   0    Yes
                                                                                    Gunther Schadow
                                                                                                      Regenstrief
                                                                                                      Institute
Duplicate of #46                     Jay Lyle        6   0   0    Yes
                                                                                    Gunther Schadow Regenstrief
                                                                                                    Institute
The RIM mapping is not part of the                   6   0   0
analysis model.                                                                     Gunther Schadow Regenstrief
                                                                                                    Institute
We need to reach out to FDA for a
definition of the use case (Randy
                                                                                    Randy Levin
Levin)
                                                                                                      FDA
The RIM mapping is not part of the                   6   0   0
analysis model.
                                                                                    Gunther Schadow
                                                                                                      Regenstrief
                                                                                                      Institute
The comment is not actionable.                       6   0   0
                                                                                    Gunther Schadow Regenstrief
                                                                                                    Institute
DAP is not a recognized HL7
artifact and it would confuse
                                                                                    Freida Hall                          Luigi Sison
reviewers.                                                                                            US Department of
                                                                                                      Veterans Affairs
It's routine practice to use upper
camel for class names.                                                              Freida Hall       US Department of Luigi Sison
                                                                                                      Veterans Affairs




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                        33                                                                        March 2003
                                                          V3 Ballot Submission/Resolution Form

It's routine practice to use upper
camel for class names.                                                               Freida Hall       US Department of Luigi Sison
                                                                                                       Veterans Affairs
It's routine practice to use upper
camel for class names.                                                               Freida Hall       US Department of Luigi Sison
                                                                                                       Veterans Affairs
It's routine practice to use upper
camel for class names.                                                               Freida Hall       US Department of Luigi Sison
                                                                                                       Veterans Affairs
It's routine practice to use upper
camel for class names.                                                               Freida Hall       US Department of Luigi Sison
                                                                                                       Veterans Affairs
We will address many of the specific                 6    0   0
comments as noted.
                                                                                     Gunther Schadow
                                                                                                       Regenstrief
                                                                                                       Institute
The RIM mapping is not part of the                   6    0   0
analysis model.
OCL is part of the DCM
methodology.
                                                                                     Gunther Schadow


                                                                                                       Regenstrief
                                                                                                       Institute

                                                                                     Freida Hall       US Department of Luigi Sison
                                                                                                       Veterans Affairs
This is not an R-MIM                                 6    0   0
                                                                                     Gunther Schadow
                                                                                                       Regenstrief
                                                                                                       Institute
It's routine practice to use upper
camel for class names.                                                               Freida Hall       US Department of Luigi Sison
                                                                                                       Veterans Affairs
This is a domain analysis model not                  12   1   2
an RIMIM or DMIM. Please refer to
the HDF.




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                         34                                                         March 2003
                                                          V3 Ballot Submission/Resolution Form

The Common Product Model is a V3                     12   1   2
model therefore it is not applicable
in analysis. However, the only
possible link between the two may
be that Common Product Model                                                         Gunther Schadow
deals with labeling which is not a
primary concern of clinicians but it's
relevant to asset management.                                                                           Regenstrief
                                                                                                        Institute
We are not Dutch and we are                          12   1   2
producing a DAM not a RMIM. The
product labeling specified in the
Common Product Model may be
aused by implementer to identify
device properties but it's not a direct                                              Gunther Schadow
requirement according to the use
cases. Location and asset
management require careful labeling
properties. The relationship between
these models is tangential.                                                                             Regenstrief
                                                                                                        Institute
This document is intended to focus
on a subset of DCMs for Medical
Device interoperability. The DCM
methodology is the subject of an
informative ballot from Patient Care.                                                Christof Gessner
The DCM Information specification
will be the definitive methodology
for DCM. The DAM methodology is
already documented in the HDF.

To support clinical observations,
we will consider additional
properties (e.g., time,
interpretations). Persistent
reference data such as ranges
will be handled in another
formalism, also incomplete.

We are developing guidelines for
vocabulary use; LOINC is an
obvious contender for this use.




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                         35                                         March 2003
                                                     V3 Ballot Submission/Resolution Form

Agreed.


We are developing guidelines for
vocabulary use; the point at
which specific value sets are
bound will be determined by that
effort.
We expect that the constrained
representation will be SBADM.

The analysis model documents
information requirements from a
specific clinical process. How
those requirements are met (by
data store, query, reference) is a
question for a later phase.




The user interface will be
addressed by a future team.




We are developing guidelines for
vocabulary use; LOINC is an
obvious contender for this use.



The analysis model documents
information requirements from a
specific clinical process.

We expect that the constrained
model will lean on existing
assets.




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                    36                    March 2003
                                                     V3 Ballot Submission/Resolution Form




The intent is to model general
reference ranges.

The analysis model documents
information requirements from a
specific clinical process. How
those requirements are met (by
data store, query, reference) is a
question for a later phase.




I don't understand
We are developing guidelines for
vocabulary use; LOINC is an
obvious contender for this use.

The semantic distinction the
comment draws between LOINC
and SNOMED is not clear.




I don't understand




Units will be handled as PQ, not
specified in the model.




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                    37                    March 2003
                                                     V3 Ballot Submission/Resolution Form

Agreed.




I don't understand




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                    38                    March 2003
                                                     V3 Ballot Submission/Resolution Form




Submitter
Tracking ID Referred To   Received From     Notes




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                    39                    March 2003
                                                     V3 Ballot Submission/Resolution Form




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                    40                    March 2003
                                                                  V3 Ballot Submission/Resolution Form



eg.Staudenmaier@va.gov



eg.Staudenmaier@va.gov




eg.Staudenmaier@va.gov




             06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                    41                    March 2003
                                                                  V3 Ballot Submission/Resolution Form




eg.Staudenmaier@va.gov




             06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                    42                    March 2003
                                                     V3 Ballot Submission/Resolution Form




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                    43                    March 2003
                                                     V3 Ballot Submission/Resolution Form




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                    44                    March 2003
                                                                  V3 Ballot Submission/Resolution Form




eg.Staudenmaier@va.gov




             06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                    45                    March 2003
                                                     V3 Ballot Submission/Resolution Form




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                    46                    March 2003
                                                     V3 Ballot Submission/Resolution Form




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                    47                    March 2003
                                                     V3 Ballot Submission/Resolution Form




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                    48                    March 2003
                                                     V3 Ballot Submission/Resolution Form




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                    49                    March 2003
                                                     V3 Ballot Submission/Resolution Form




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Ballot]                    50                    March 2003
                                                 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.




06715989-5534-44c7-966c-2113caed2ad8.xlsx [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".


06715989-5534-44c7-966c-2113caed2ad8.xlsx [Instructions]                                                                                  August, 2002
                                           Ballot Submission/Resolution Instructions

 Vote/Type               Negative Votes:

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

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

                         Affirmative Votes:

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

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

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

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

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




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Instructions]                                                                                 August, 2002
                                           Ballot Submission/Resolution Instructions

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




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Instructions]                                                                               August, 2002
                                             Ballot Submission/Resolution Instructions

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

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

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

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

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

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

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




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Instructions]                                                                                  August, 2002
                                            Ballot Submission/Resolution Instructions

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


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

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


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



06715989-5534-44c7-966c-2113caed2ad8.xlsx [Instructions]                                                                                  August, 2002
                                          Ballot Submission/Resolution Instructions

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




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Instructions]                                                                          August, 2002
                                         Ballot Submission/Resolution Instructions




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Instructions]                             August, 2002
                                         Ballot Submission/Resolution Instructions




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Instructions]                             August, 2002
                                             Ballot Submission/Resolution Instructions

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

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

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

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

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

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


06715989-5534-44c7-966c-2113caed2ad8.xlsx [Instructions Cont..]                                                                                August, 2002
                                            Ballot Submission/Resolution Instructions
(60%) of the combined affirmative and negative votes cast by the Work Group during reconciliation.” Example scenarios include, but are not limited to;
- the submitter is commenting on a portion of the standard, or proposed standard, that is not part of the current ballot
- the submitter's comments may be persuasive but beyond what can be accomplished at this point in the ballot cycle without creating potential
controversy.
- the submitter is commenting on something that is not part of the domain

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

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

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

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

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

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




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Instructions Cont..]                                                                             August, 2002
                                                          Ballot Submission/Resolution Instructions




     int the

econciliation




 Comments.




           of

st indicate a




                06715989-5534-44c7-966c-2113caed2ad8.xlsx [Instructions Cont..]                       August, 2002
                                                         Ballot Submission/Resolution Instructions




en submitted


more input




t no change




 some WG's




               06715989-5534-44c7-966c-2113caed2ad8.xlsx [Instructions Cont..]                       August, 2002
                                                               V3 Ballot Submission/Resolution Form


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

  1) The cell is pre-set to word wrap

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

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

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

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




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Format Guidelines]                         64                                                March 2003
                                                            V3 Ballot Submission/Resolution Form




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Format Guidelines]                65                    March 2003
                                                             V3 Ballot Submission/Resolution Form


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

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

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


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


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

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

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


06715989-5534-44c7-966c-2113caed2ad8.xlsx [Co-Chair Guidelines]                        66                                                                              March 2003
                                                              V3 Ballot Submission/Resolution Form

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


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


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

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

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

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

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

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


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


06715989-5534-44c7-966c-2113caed2ad8.xlsx [Co-Chair Guidelines]                          67                                                                               March 2003
                                                               V3 Ballot Submission/Resolution Form

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

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


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

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


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


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


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

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

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

06715989-5534-44c7-966c-2113caed2ad8.xlsx [Co-Chair Guidelines]                          68                                                                                March 2003
                                                               V3 Ballot Submission/Resolution Form


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

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




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Co-Chair Guidelines]                          69                                                                                March 2003
                                                            V3 Ballot Submission/Resolution Form




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Co-Chair Guidelines]              70                    March 2003
                                                                           V3 Ballot Submission/Resolution Form


, or replaced by use cases)


lots returned on unmarked items will be found

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

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



       persuasive.· In all cases, the voter must

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




to vote.· Out of scope items




management tool. Question will be removed.

ive with comment – typonaffirmative with




ws 15.07.03). The TSC Chair will determine




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


               06715989-5534-44c7-966c-2113caed2ad8.xlsx [Co-Chair Guidelines]              71                    March 2003
                                                                            V3 Ballot Submission/Resolution Form

 of the affirmative comment and whether or not




 ust notify the ballotter of this disposition.




whether or not the respondent has withdrawn



 nion as to whether or not Technical

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




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

nt to HL7 HQ by email or fax.

otes with the negative balloters. The negative




                06715989-5534-44c7-966c-2113caed2ad8.xlsx [Co-Chair Guidelines]              72                    March 2003
                                                                           V3 Ballot Submission/Resolution Form




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




C? Yes· How should non-substantive changes




owances for “Guideline Not Found”.




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




               06715989-5534-44c7-966c-2113caed2ad8.xlsx [Co-Chair Guidelines]              73                    March 2003
                                                                            V3 Ballot Submission/Resolution Form



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



he ballot (as it currently seems to state in the




                06715989-5534-44c7-966c-2113caed2ad8.xlsx [Co-Chair Guidelines]              74                    March 2003
                                                            V3 Ballot Submission/Resolution Form




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Co-Chair Guidelines]              75                    March 2003
Ballot Committee Code   Ballot Committee Name Ballot Code Name

InM                     Infrastructure and      CT
                        Messaging               XML-ITS DataTypes

                                                XML-ITS Structures

                                                Datatypes Abstract
                                                MT
                                                TRANSPORT
                                                UML-ITS DataTypes

                                                CI, AI, QI
                                                MI

CBCC                    Community Based         MR
                        Collaborative Care


CDS                     Clinical Decision Support DS

CS                      Clinical Statement      CS

FM                      Financial Management    AB
                                                CO
                                                CR

II                      Imaging Integration     DI
                                                II

M and M                 Modelling and           RIM
                        Methodology             Refinement
                                                CPP
                                                MIF
                                                HDF

MedRec                  Medical Records (now    MR
                        merged with SD)

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


PA           Patient Administration   PA
                                      MM
                                      SC

PC           Patient Care             PC

PM           Personnel Management     PM

PHER         Public Health /          IZ
             Emergency Response       PH
                                      RR

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

RCRIM        Regulated Clinical Research Information Management
                                      RP
                                      RT

Sched        Scheduling               SC

StructDocs   Structured Documents     CD
                                      QM

Vocab        Vocabulary               Vocabulary (ref)
                                      Glossary (ref)

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

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

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

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


Version 3: Clinical Decision Support, Release 1

Version 3: Clinical Statement Pattern, Release 1

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

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

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

Version 3: Medical Records, Release 1, 2


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


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

Version 3: Care Provision, Release 1

Version 3: Personnel Management, Release 1

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

Version 3: Guide
Version 3: Backbone

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

Version 3: Scheduling, Release 1, 2

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

Version 3: Vocabulary
Version 3: Glossary
Type of Document

Domain

Foundation

Foundation
Foundation
Domain
Foundations

Foundation
Domains
Domain



Domain

Domain

Domain

Domain
Domain
Domain

Domain
Domain

Foundation
Foundation
Foundation
Foundation
Foundation



Domain

Domain
Domain
Domain
Domain
Domain
Domain
Domain
Domain
Domain
Domain



Domain
Domain
Domain

Domain

Domain

Domain
Domain
Domain

Reference
Reference

Domain
Domain

Domain

Domain
Domain

Foundation
Reference
                                                            V3 Ballot Submission/Resolution Form

This page reserved for HL7 HQ. DO NOT EDIT.




                      Affirmative Negative



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




Yes                   No


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

HD
AR
RM
IN
TE
MT
DM
ST
??




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Setup]                                     82                                                                           March 2003
                                                    V3 Ballot Submission/Resolution Form

                                                         ArB,Atta
                                                         ch,Cardi
                                                         o,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,P
                                                         ublishing
                                                         ,RCRIM,
                                                         RX,Sche
                                                         d,Securit




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Setup]                    83                    March 2003
                                                                           V3 Ballot Submission/Resolution Form




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




              06715989-5534-44c7-966c-2113caed2ad8.xlsx [Setup]                                      84                                                                             March 2003
                                                    V3 Ballot Submission/Resolution Form




06715989-5534-44c7-966c-2113caed2ad8.xlsx [Setup]                    85                    March 2003
                                                                 V3 Ballot Submission/Resolution Form




omment can be scheduled for discussion.




             06715989-5534-44c7-966c-2113caed2ad8.xlsx [Setup]                    86                    March 2003

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:0
posted:5/14/2013
language:Unknown
pages:86
tang shuming tang shuming
About