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                             Plenary Week, Sept. 15-19, 2008

Monday
Q1 Plenary Session             Agenda Items                       Co-chairs
Q2 Plenary Session
Q3 SD Solo                     Agenda planning
                               Product & Services Guide
Q4 SD Solo                     Ballot: QRDA
Tuesday
Q1 SD Solo                     Ballot, open: QRDA/HAI II
Q2 SD Hosts: Device            Joint Ballot : PHM                 bd @ vocab
Q3 SD Hosts: II                Joint Ballot: DIR
Q4 SD Solo                     Ballot: SDA – Need Q4 Wed?         [la, bd at BoD]
Wednesday
Q1 SD Solo                     Ballot: Op Note                    Intro [la]
                                                                  Decision support [kb]
Q2    SD Solo                  Ballot: Op Note/QRDA               Intro [la]
                                                                  Decision support [kb]
Q3    SD Solo                  Ballot: V2 Ch 9 (confirm w/Tony)   Adv [bd, cb]
                               Short meeting                      Patient Care [kb]
Q4 SD Solo                     Ballot, open                       Adv [bd, cb]
Thursday
Q1 SD Solo                     Ballot: PHM/DIR                    CDA Cert [cb]
                                                                  Decision support [kb]
Q2 SD Solo                     Ballot: DIR/PHM                    CDA Cert [cb]
Q3 SD Solo                     Ballot: SDA ballot                 [cb] Clinical Statement
Q4 SD Solo                     Ballot: HAI II                     [cb] Clinical Statement
Friday
Bkf Breakfast Mtg              Agenda Planning                    Co-chairs only
      7:00 AM
Q1    Term-Info Project
Q2    Term-Info Project


Potentials:
    Wednesday Q4: HAI II

Additional Topics
Jim C. – Order Sets Ballot
                                     Structured Documents
                                              Attendance List
Monday
Name                     Email                                   Plenary      Q3 Q4
Keith Boone              keith.boone@ge.com                                   X      X
Rick Geimer              rick@alschulerassociates.com                         X      X
Hiro Hoshimoto           Hhoshi-tky@umin.ac.jp                                X      X
Cecile Pistre            Cecile.postre@sarnofi_overtis.com                    X
Kate Hamilton            kate@alschulerassociates.com                         X      X
Brett Marguard           Brett@alschulerassocaites.com                        X      X
Pele Yu                  Fyu@peds.uab.edu                                     X      X
Randolph Barrows         Rbarrows@medallies.com                               X      X
Crystal Kellem           Crystal.kallem@ahima.org                             X      X
Joe Forbes               jsforbes@mmm.com                                     X
Liora Alschuler          liora@alschulerassociates.com                        X      X
Ryan Murphy              Ryan.w.murphy@us.army.mil                            X      X
Bob Dolin                BobDolin@gmail.com                                   X      X
Gay Giannone             gay@alschulerassociates.com                          X      X
Fred Behlen              fbehlen@laitek.com                                   X      X
Calvin Beebe             cbeebe@mayo.edu                                      X      X
Thomson Kuhn             tkuhn@acponline.org                                  X      X
Bob Yencha               Bob@alschulerassociates.com                          X      X
Vincent Mccaney          Vincent@mccaneySoftware.com                                 X


Monday Q3 SDWG Minutes
SD Solo    Agenda planning: invite conf?

Op Note Ballot reconciliation
The official ballot responses are recorded in the ballot worksheets.
The following notes are provided for convenience.
#6 Please be more specific in the value set of SNOMED CT to use.
Motion: Find persuasive.
Vote - For 14 against 0 abstain 3

Product & Services Guide Discussion
Jill highlighted the product and services guide for the group. After the meeting the link
will be put on the web.

Ambassador Program
30 minute talk – on CDA and CCD
    Tuesday AM presentation on V3
    Wednesday AM Presentation on Clinical Genomics

Monday Q4 SDWG Minutes
SD Solo        Ballot: QRDA
The official ballot responses are recorded in the ballot worksheets.
The following notes are provided for convenience.

#1 Comments from Bob - Consider differentiating between "stratification" and "aggregation". The
former refers to patient characteristics (e.g. age, sex, ethnicity), defined within a measure. The latter are not
patient characteristics (e.g. provider, location), and can be defined by the recipient. QRDA will get the
former from the measure definition, but will need to get the latter from the particular recipient.

The category 1 defines the elements required by the measure and for aggregation?
Additional data to meet local requirements are restricted. Comment no vote.

Comments from Ryan Murphy
Voted negative with open issues / persuasive that we need to close the open issues.
14 total

Motion: we must close the open issues.
For 14      Against: 0 Abstain: 0                               Motion passes

Moving on to Keith’s comments:
#33 - If these values are from the EMR, they will not be characterized as “initial”, only
by date/time.

Comments: The measure calls for sending the first pulse reading. Send the data element
that represents the reading that is wanted. Shouldn’t the requirements for the measure be
indicated as called for in the measure (first). It’s a feel good narrative. There was some
question about the alignment of the narrative to the measures that are recorded in the
entries found in the document. Bob suggested that we look at the entries to ensure that we
have the entries correct, and then look at the appropriate narrative representation.

What are the reuse requirements of the data?

It was proposed that the narrative be derived from the entries and not feel good.
What does QRDA assert about narrative and entry? It should be derived “derv”.

The notion that we want to strive with derived, the narrative needs to be derv from the
entry.

Motion: Remove the word initial from the narrative block.
For: 13     Against:      0        Abstain:      1       Persuasive Motion passes
Tuesday - SDWG meeting
Name                   Email                               Q1 Q2 Q3 Q4
Liora Alschuler        liora@alschulerassociates.com       X   X   X
Rick Geimer            rick@alschulerassociates.com        X   X   X
Ryan Murphy            Ryan.w.murphy@us.army.mil           X   X   X
Gay Giannone           gay@alschulerassociates.com         X   X   X
Kate Hamilton          kate@alschulerassociates.com        X   X
Keith Boone            keith.boone@ge.com                  X   X
Rob Hausam             Robert.hausam@theradoc.com          X   X
Brett Marguard         Brett@alschulerassocaites.com       X   X
Marla Albitz           2hx4@cdc.gov                        X   X
Daniel Pullock         Dap1@cdc.gov                        X   X
Ilkon Kim              ikkim@knu.ac.ky                     X   X
Aden Hirchly           Ades.hinkly@ceevels.com             X   X
Jim Forbes             Jim.forbes@uhn.on.cc                X   X
Bob Dolin              BobDolin@gmail.com                  X   X
Andrew Perry           Andrew@clininfo.ur                  X
Bob Yencha             Bob@alschulerassociates.com         X
Pele Yu                Fyu@peds.uab.edu                    X
Randolph Barrows       Rbarrows@medallies.com              X
Crystal Kallem         Crystal.kallem@ahima.org            X
Joann Larson           Joann.Larson@kp.org                 X
Thomson Kuhn           tkuh@acponline.org                  X
Jim Campbell           Campbell@ummc.edu                           X
Tod Ryal               trial@cerner.com                            X
Cecile Pistre          Cecile.postre@sarnofi_overtis.com           X
Ken Grelach            kgerlach@cdc.gov                            X
David Hay              David.hay2s@gmail.com                       X
Hiro Hoshimoto         Hhoshi-tky@umin.ac.jp                       X
Nathan Hulse           Nathan.hulse@imail.org                      X
Howard Clark           hclark@medicalimaging.org                   X
Dick Donker            Dick.Donker@philips.com                     X
Helmut Koenig          Helmut.koenig@siemens.com                   X
Fred Behlen            fbehlen@laitek.com                          X



Tuesday Q1 SD Solo                     Agenda Ballots: QRDA/HAI II
Ballot reconciliation QRDA / HAI II ballots
The official ballot responses are recorded in the ballot worksheets.
The following notes are provided for convenience.

Tuesday Q2 SD Hosts: Device            Agenda - Joint Ballot : PHM
Ballot reconciliation PHM ballot
The official ballot responses are recorded in the ballot worksheets.
The following notes are provided for convenience.

Tuesday Q3 SD Hosts: II                Agenda - Joint Ballot: DIR
Ballot reconciliation DIR ballot
The official ballot responses are recorded in the ballot worksheets.
The following notes are provided for convenience.
Wednesday - SDWG meeting
Name                    Email                                 Q1 Q2 Q3 Q4
Gay Giannone            gay@alschulerassociates.com           X      X     X      X
Bob Dolin               BobDolin@gmail.com                    X      X
Calvin Beebe            cbeebe@mayo.edu                       X      X
Joe Forbes              jsforbes@mmm.com                      X      X
Crystal Kallem          Crystal.kallem@ahima.org              X      X
Floyd Eisenberg         Floyd.eisenberg@siemens.com           X      X
James Mhyre MD          j.mhyre@poliancesurgeons.com          X      X
Peter Hendler                                                 X
Ken Gerlach                                                   X
Keith Boone             keith.boone@ge.com                                 X
Francos McCary                                                             X
Jingdong L                                                                 X
Andree MacLean                                                             X
Mary Kennedy            Mkennedy@cop.org                                   X
Adri Burggraaff         Adri.buggroaff@slz.nl                              X
Tony Julian             ajulian@mayo.edu                                   X
Marla Albitz                                                                      X
Daniel Pullock          Dap1@cdc.gov                                              X
Brett Marguard          Brett@alschulerassocaites.com                             X
Sylvia Thun                                                                       X
Frank Oemig                                                                       X
Liora Alschuler         liora@alschulerassociates.com                             X
Rob Kausam                                                                        X
Bob Yencha              Bob@alschulerassociates.com                               X



Wednesday Q1 - Review of the Op Note Ballot
The official ballot responses are recorded in the ballot worksheets.
The following notes are provided for convenience.

Floyd Eisenberg – Ballot Reponses
#2 The Table lists Complications as Optional. Considering the amount of public reporting and
transparency required, especially in the US, it seems Complications should be a required field with
potentially codified elements. I believe this could be managed with a null value if no complications
existed.

To what extent do we need to accommodate the variation, to what extent do we want to be prescriptive.
Given this is a DSTU, we should consider the latter.

A question of how to model that there are No Complications Vs the surgeon did not report any
complications.

Make the section required, and if the surgeon does not report, indicate None reported.
Persuasive with mode
Abstain: 1 Against: 0 For: 8                    Motion Passes

#3 The operative note could be more generic if the description allowed (a) narrative description, and (b)
optional discrete data elements required for specific procedures. E.g., for a post-operative colonoscopy
report elements such as time of initiation of procedure, distal extent of procedure and time at which distal
extent reached, and time of completion. These elements can then be used as part of aggregate performance
and quality analysis. In general the time of various components of the procedure are important in the
operative note such that performance measure analysis can be accomplished. Incision time, closure time,
etc. would be very helpful here.

The standard supports additional sections and entries as needed to be added as required.
Non -Persuasive
Abstain: 1 Against: 0 For: 8                  Motion Passes

#4 There should be a generic section for items implanted, inserted such that the item can be discretely
identified (e.g., type of drain, specific prosthesis, specific pacemaker, cadaveric bone graft, etc.). Such
implanted / inserted items can (optionally) be identified by manufacturer and lot number. Since multiple
devices or items may be placed into the patient, the section must allow multiple components to be
identified. Such modification to a standard operative note allows more facile data collection for analysis
and measurement to determine effectiveness.

Add an optional implant section, we will cross reference with Jim’s comments.
Persuasive with mode
Abstain: 1 Against: 0 For: 8                  Motion Passes

#5 It seems to me that we're trying to have it both ways on this section. Can the presence of the EBL
information be enforced on the basis of this conformance statement or not? In my view, we should either
come up with an enforceable conformance statement or admit that this is not a machine-enforceable
requirement.
Persuasive
Abstain: 1 Against: 0 For: 8                  Motion Passes

Op Note Ballot comments - James Mhyre, MD
#1 Many if not most facilities are directed by their malpractice insurance carriers to do instrument counts
for all but very small incisions. Needle and sponge counts are done universally while instrument counts are
not done everywhere or with every case. If the standard is to include sponge and needle counts
specifically, then it should also include a section to document that an instrument count was completed.

The primary data regarding counts is documented by the circulating nurse in the facility operative record.
It is not clear what the purpose is to include statements that these counts were done well after the fact in the
surgeon's operative report dictated in the post operative period. In a legal dispute where something was left
in, the facility record is the primary source, not the operative report.
Persuasive – resolution recorded in the ballot worksheet
Abstain: 0 Against: 0 For: 8         Motion Passes

#16 Implants:
We must document what we take out of patients as operative specimens and how much blood loss is
incurred but we are not required to document what we put into patients. We are putting in more and more
prosthetic devices including total joint arthroplasties, hernia mesh products, venous access devices, heart
valves, and pacemakers. We also place biological materials such as cadaver bone grafts or porcine dermal
mesh devices. These details are captured by the facility procedure record and can be researched in the
facility record if needed. It would be useful to include this in the operative note as well because the op note
is more widely available. The implants are usually mentioned in the text of the note but it would be useful
to have a separate header category for implant details in XML searchable fields. I am suggesting the
following four categories although this merits wider research and comment:
Implant n
     Product name n
     Manufacturer n
     Model number n
    Serial number n
Implants should be a multiple, 0 to n, category.

Persuasive – resolution recorded in the ballot worksheet
Abstain: 0 Against: 0 For: 8         Motion Passes

#17 Photographs:
Can the CDA accommodate jpeg files or some other imaging standard? We are now doing much of our
surgical work with video technology and we can capture photographs and even video clips. Our current
technology allows us to print the pictures, save them on a USB drive, or burn a CD or DVD. We
commonly see pathology that we want to document with photographs for future reference. Pictures are
worth a thousand words. However, we have no good way to save them integrated in an electronic record.
An example is taking a photograph of a nodule in the liver or an ovarian cyst found incidental to another
procedure. Most modern ORs are going to more wired systems where the video towers are integrated into
the network running the OR. Since there are only a few equipment vendors they could quickly implement
the ability to capture and send select images to the network and on to a dictation module to be incorporated
into an operative note as a jpeg file. The future rendering of the report would then depend on the display
medium and its ability to display photographs along with the text. The standard should include the option
for multiple photographs along with a free text caption for each. GI lab systems for endoscopy reports
already incorporate photographs in their procedure reports, at least in their current paper versions.

Response – CDA currently supports this and not precluded.
Break


Wednesday Q2 continued OP Note Ballot reconciliation
#18 Carbon Copies:
In our dictations we commonly direct the facility HIM staff to forward a copy of the document to one or
more providers or other entities, occasionally the patient them self. While we no longer use carbon paper
we are still using paper documents via fax in most locals. Our OP note standard should have a CC section
to specify who is to receive a copy. The HIM staff would then send it by whatever system is in place
including fax or pushed electronically to specific entities such as the PHR and primary care EHR.
The CC list at the bottom not only directs the staff where to send copies but it notifies future readers who
received a copy previously.

Response – CDA header supports CC this and not precluded.

#19 The Operative Note is only one of four records of the procedure.
For operations done in a facility such as a hospital operating room, there are typically four records created,
the facility operative report created by the circulating nurse, the anesthesiology record created by the
anesthesiologist, the brief operative note typically hand written in the progress notes by the surgeon used to
direct care in the immediate post operative period, and finally the operative note which is the subject of this
DSTU. There is considerable duplication of data elements, many on all four documents. Some data
elements are primary to one and copies on the others. Fluids, medications, and vital signs are primarily
recorded on the anesthesia record. The estimated blood loss is most useful in the brief op note to direct
post operative care. The names of all personnel in the operating room during the case including observers,
incision time, room in and out times, sponge, needle and instrument counts, documentation regarding
implants including vendor supplied stickers with serial numbers and occasionally bar codes, and
medications used on the field such as local anesthetics are recorded by the circulating nurse on the facility
OP record. The needle, sponge, and instrument counts described in the DSTU operative note are copies of
the primary data in the facility record. It is not clear if they serve a role in the operative note other than to
document what the surgeon understood from the circulating nurse regarding counts. In cases where
sponges were left in, including one of my own, the sponge counts were always “correct.” It does not matter
what is documented in the surgeon’s operative note, it is the facility RN operative note that contains the
primary data.
Motion: There are technical mechanism for achieving and will consider for future use.
Abstain: 0      Opposed: 0              For: 7          Motion Passes

Motion: We will incorporate changes from ballot reconciliation and publish Op Note as DSTU with
out re-balloting.      Motion by: Bob            Second : Crystal Kellem

Abstain: 0          Opposed: 0                  For: 7              Motion Passes

Do we need to provide informative guide on how this CDA IG could work?

James Mhyre, MD – has offered to take the guide to surgical societies. Bob noted some concerns about
how the IG does not talk about the extensions that are permissible.


QRDA
Comments from Floyd Eisenberg
#46 The implementation of quality reporting through HITSP and IHE efforts thus far have provided
for Pseudonymization of patient identities and anonymization of data elements. QRDA likely can
accommodate a pseudonymized patient identifier without difficulty. However, what is the
potential for anonymized data elements for a category 1 report potentially changing the meaning,
and thus the subsequent calculated performance, with respect to the measure?

Anonymization - to protect the patients identify / confidentiality.

There is currently in the RIM (current release) MSK as NULL value. This could be used to support these
requirements.

Motion: We will add a comment that if you need to anonumize data, then use MSK.
Persuasive For: 6 Against: 0 For: 0 Motion passed

#48 Rewording
Original: Definition of a Quality Measure and QRDA’s Role –NOTE: “Even though a measure-specific
implementation guide will define a formal representation of a measure, this doesn't necessarily mean there
is consistent capture of that measure within an institution. For example, an observation that ACE Inhibitors
are contraindicated may be captured as an allergy, a diagnosis, as free text, et cetera, even within a single
organization.”

Revised Wording: “A measure-specific implementation guide defines a formal representation of a
measure, but does not necessarily specify the data elements and their context in the granularity required to
identify them within an EHR. For example, an observation that ACE Inhibitors are contraindicated may be
represented in an allergy list, in a problem list, in a diagnosis list, as free text in a clinical note, even within
a single organization. Separate efforts are in progress to encourage modification to measure specifications
to accommodate data representations in the EHR. Such efforts may reduce manual abstraction
requirements and enable more direct coordination of QRDA with an electronic output of an EHR.”
Motion: Accepted rewording.
Persuasive For: 6 Against: 0 For: 0 Motion passed

#49 Comments
The figure suggests that the measure can be directly modeled in QRDA format and reported by
the provider, with the presumption such reporting can be automatic. As measures are defined
today, there is significant manual effort with respect to abstraction or analyzer actor activity
surrounding the EHR to massage the data into QRDA acceptable format. The figure does not
account for the need for such activity and it should do so. Figure 1. – the high level flow.
Discussion: The group revised the diagram to clarify the process used for measurement developed.
Motion: Fix the figure.
Persuasive For: 6 Against: 0 For: 0 Motion passed

#50 & #51 - Revised wording proposed.
Add bullet for Professional Societies – Participate in formalized processes for measure specification
modeling
Motion: Accept rewording
Persuasive For: 6 Against: 0 For: 0 Motion passed

#52 Figure 12
The listed items, PN-1 Oxygen Assessment, PN-4 Adult Smoking Cessation, PN-6a Initial
Antibiotic Selection for CAP in Immunocompetent ICU Patient, represent carefully specified data
elements in manual specifications. These data elements must be presentable in terms of value
sets that represent compliance for expected patient instances for each element. For each patient
output report, the element can be present or absent (e.g., Y / N). However, if the QRDA is to at
some later iteration represent the measure specification itself, more detail is required here to
identify appropriate compliant instances from non-compliant instances.

Assertion: We only include qualifying data elements for inclusion, we need to be sure it is clear in the
explanatory text.
Persuasive with Mod For: 6 Against: 0 For: 0 Motion passed



Wednesday Q3 Ballot: V2 Ch 9
Meeting with Tony Julian to review the Chapter 9 HL7 V2 – Ballot comments.
The official ballot responses are recorded in the ballot worksheets.
The following notes are provided for convenience.
Thursday - SDWG meeting
Name                  Email                               Q1 Q2 Q3 Q4
Gay Giannone          gay@alschulerassociates.com         X   X        X
Bob Dolin             BobDolin@gmail.com                  X   X        X
Liora Alschuler       liora@alschulerassociates.com       X   X
Harry Soloman         Harry.soloman@ge.com                X   X
Keith Naylor          Keith.naylor@nhs.net                X   X
Bob Yencha            Bob@alschulerassociates.com         X
Randy Carroll                                             X
Rick Geimer           rick@alschulerassociates.com        X   X
Dick Donker           Dick.Donker@philips.com             X
Igor                                                      X
Fred Behlen           fbehlen@laitek.com                  X
Kevin Coona                                                   X
Keith Boone           keith.boone@ge.com                      X
Ian Towwend                                                   X
Adri Buroggraaff                                              X
Floyd Eisenberg       Floyd.eisenberg@siemens.com                      X
Frank Oemig           HL7@oemig.de                                     X
Jennifer Puyenbroer   jpez@cdc.gov                                     X
Daniel Pollock        dpollock@cdc.gov                                 X
Marla Albitz          malbitz@cdc.gov                                  X
Brett Marguard        Brett@alschulerassocaites.com                    X
Rob Hausam            Robert.hausam@theradoc.com                       X
Cecile Pistre         Cecile.postre@sarnofi_overtis.com                X
Kate Hamilton         kate@alschulerassociates.com                     X


Thursday Q1 - SD Solo Session
Ballot Reconciliation on PHM/DIR
The official ballot responses are recorded in the ballot worksheets.

Thursday Q2 - SD Solo Session
Ballot Reconciliation on DIR/PHM
The official ballot responses are recorded in the ballot worksheets.

Thursday Q3 - SD Solo Session
Ballot Reconciliation on SDA ballot
The official ballot responses are recorded in the ballot worksheets.

Thursday Q4 - SD Solo Session
Ballot Reconciliation on HAI II
The official ballot responses are recorded in the ballot worksheets.
Notes from joint meeting with OO / PC and SD on Clinical Statement
The following material is provided for reference, but no not represent the official minutes from the
Clinical Statement meeting. Please refer to the Clinical Statements Work Group HL7 web page to access
the official minutes.

Q3 – Thursday – Clinical Statements

New Work Group Status

Motion: That the project be moved to Work Group.

Work Group – Clinical Statements
As a work group – the Clinical Statements can schedule meetings as it needs to.
Do we want to stick in principle to meet only Thursday PM
Conference Calls – a bit up and down on the attendance.
There will not be a conference call unless there is an issue that needs to be worked on?
         Will have conference calls as needed.
         Mission and Charter Statement - Help review the mission and charter statement
         Need to review the decision making document
         Quorum requirements- 4 people excluding the chair.
         Passed.

Need to add my name (Calvin Beebe) to the clinical statement listserv.

The DSTU will run out the end of December.

There are some change request that have not been applied. The model has been updated with the change
requests on the Wiki. Are the updated models available?

Ensure that the model is updated, do we move to a new model via DSTU

May 2009 – Go into ballot Normative on Clinical Statement Model round in May 2009 Normative

There are 4 change request approved and not applied.
Those that are pending – there were requests sent to submitters requesting they review their old requests,
prior to dropping them if they do not respond back.

Changes need to get into the Clinical Statement model.
Need a new project statement to go normative status.
Someone from the ARB join the room
Harmonize the Medication / Prescription – We want to achieve that the Pharmacy DMIM be consistent.

It would be helpful to have some questions that could be used to indicate if a domain should include the
clinical statement model.
On the pharmacy side their work is preliminary.

Attribute level descriptions – Bug fix for DMIM tooling of printing attributes.

There are a number of fields that need to be placed into Visio and then which ones do we want to have in
the ballots.

We need to review this with publishing:
Definition                          Must
Rational                            Maybe
Implementation Notes       Maybe
Design Comments                     Maybe
Issues                              Maybe
History                    Maybe
Mapping                             Maybe
Business Name              Maybe

Should we have mapping between the Clinical Statements and the source committees.

We need to complete the attribute definitions on the Clinical Statement model prior to going to ballot.

Looking for some folks to help on attributes within the model.

Q4 – Clinical Statement WG – Continued…
The ARB will take a look at what it means to get other groups to link with the Clinical Statement. The ArB
and TSC will pull that together. Moving forward with a Normative expression was supported by John.

Medication – Gary is working with Canada - Pharmacy and Medication models aligned with the HL7
Models and them link together.

Project Statement– Clinical Statement Pattern goes Normative
How to go normative – DMIM or RMIM

Does the TSC want to be in the loop or endorse the motion to move the DSTU to the normative status?
Note to the chair of the TSC about moving forward with a project to normative status.

CMETs – There are two of them. They have not been touched for over a year. Patrick and Charlie to
access current state on what needed to get CMETs in Sync with most current pattern.

Clinical Statement – Clinical Genomics

Pull most current decision making process document. Support for e-mail voting.

				
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