2022-10-12 Agenda & Meeting Notes

Date

Oct 12, 2022 at 2 PM ET

Invitees

Present

Last Name

First Name

Organization

E-Mail

Stakeholder Category

Present

Last Name

First Name

Organization

E-Mail

Stakeholder Category

X

Merrick (Co-Chair)

Riki

APHL

riki.merrick@aphl.org

Professional Organization

X

Luu (Co-Chair)

Hung

University of Texas Southwestern Medical Center

Hung.Luu@utsouthwestern.edu

Healthcare Provider

 

Banning

Pamela

3M

pdbanning@mmm.com

Industry Entity

X

Campbell

Scott

University of Nebraska Medical Center

wcampbel@unmc.edu

Healthcare Provider

X

Case

Jim

SNOMED International

jca@snomed.org

Standards Organization

X

Hafeza

Eza

Regenstrief Institute

ehafeza@regenstrief.org

Standards Organization

 

Hall

Freida

ACLA

Freida.X.Hall@questdiagnostics.com

Healthcare Provider

X

Hausam

Rob

Hausam Consulting

rrhausam@gmail.com

Industry Entity

X

Heierman

Ed

Abbott

Ed.Heierman@abbott.com'

Industry Entity

 

Hiller

Carolyn

Reagan-Udall Foundation

chiller@reaganudall.org

Public - Private Partnership

X

Huff

Stan

Graphite

stan.huff@graphitehealth.io

Healthcare Provider

X

Jonnaert

Serge

IICC

serge.jonnaert@ivdconnectivity.org

Industry Entity

 

Kennedy

Mary

CAP

mkenned@cap.org

Professional Organization

X

Kegerize

Joan

ACLA

jkegerize@acla.com

Healthcare Provider

X

Nassiri

Mehdi

Indiana University

mnassiri@iupui.edu

Healthcare Provider

X

Nirmala

Nanguneri

Tufts Medical Center

NNirmala@tuftsmedicalcenter.org

Healthcare Provider

X

Phillips

Ann

IMO

APhillips@imohealth.com

Industry Entity

X

Pitkus

Andrea

University of Wisconsin

apitkus@gmail.com

Healthcare Provider

X

Polen

Molly

AACC

mpolen@aacc.org

Professional Organization

X

Rallins

Marjorie

Regenstrief Institute

mrallins@regenstrief.org

Standards Organization

 

Sapiente

Joe

MDIC

jsapiente@mdic.org

Public - Private Partnership

 

Skapik

Julia

NACHC

JSkapik@nachc.org

Healthcare Provider

 

Smith

Jeffrey

Kaiser Permanente

Jeffrey.R.Smith@kp.org

Healthcare Provider

X

Temple-Smolkin

Robyn

Association for Molecular Pathology

RTemple@amp.org

Professional Organization

Recording Link:

Goals

  • Gather feedback on Article 9 of Draft SHIELD Community Charter

  • Gather feedback on Draft Standing Rules of SHIELD Community

Discussion Topics

Time

Item

Presenter

Notes

Time

Item

Presenter

Notes

3 Minutes

Begin Meeting Recording; Roll Call

Merrick

  •  

2 Minutes

Overview of Meeting Goals and Agenda

Merrick

  •  

2 Minutes

General Announcements

Merrick / Luu

  •  

10 Minutes

Gather Feedback on Article 9 of Draft Charter

Merrick

  • ARTICLE NINE: AMENDMENTS

    • Section 1: Power to Amend Charter and Standing Rules - completed

      • added “exclusive” before power to limit this to just the Steering Committee

    • Section 2: Conditions - completed

      • clarified that it is 2/3 vote of all members “present, provided quorum is reached”

35 Minutes

Gather Feedback on Draft of SHIELD Community Standing Rules

Merrick

  • Standing Rules of the SHIELD Community

    • Rule I. Transparency - completed

      • adjusted posting of summaries to 30 days

    • Rule II. Steering Committee Meeting Agenda - completed

      • clarified that agendas are to be posted “no less than 5 days” in advance of the meeting

      • Updated the Chair or Vice Chair to “Presiding Officer (Chair or Vice Chair)” in the first instance and then used Presiding Officer afterwards

    • Rule III. Conflicts of Interest - completed, no changes made

    • Rule IV. Option Out of Advocacy and Regulatory Comment - completed

      • Added position “statement” to clarify this is a commeent, not a physical role / position

    • Rule V. Notice of SHIELD Community Representations

      • Discussion around what constitutes public:

        • Should define what we mean by public - obviously conferences, but what about a presentation within one of the member organizations of SHIELD?

          What about IVD vendors at the exhibition booth (marketing that they are part of SHIELD).

          Maybe consider if slides/recording of presentations are available on the web afterwards (for purchase or free)

      • Discussion what constitutes representing SHIELD Community

        • updates on what we are doing vs representing official SHIELD opinion

    • Rule VI Intellectual Property

      • Molly will ask an IP Lawyer friend for opinion, all are invited to have IP SMEs review this paragraph

    • Rule VII: Antitrust - completed, no changes made

    • Rule VIII: Application of Rules of Order

      • Added bullet: “The Steering Committee or Workgroup may reserve the right to identify a particular item as requiring consensus rather than the 2/3 majority vote.”

    • Definitions

      • Motion - completed, no changes made

      • Second - completed, no changes made

      • Amendment - completed, no changes made

      • Quorum - completed, no changes made

      • Presiding Officer - completed

        • Added bullet “Designating a Secretary at the beginning of each meeting”

      • Secretary

        • Removed sentence about the Presiding Offcier appointing the Secretary

        • completed EXCEPT the striken bullet:” Looking after and managing records, reports and official correspondence” - Who would have this responsibility?

5 Minutes

Closing Remarks; Set Next Re-Organization Committee Meeting

Merrick

Next week Riki is at Newborn Screening Symposium, but Hung is available, so we might still hold this call

The week of Oct 24 is LOINC meeting, so should re-schedule both the ALl SHIELD call and this call

Riki will send email with final decision out.