Last Updated 08 Sep 09 Oct 2022

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The SHIELD Community was chartered in 2022 as a natural evolution of prior industry and government efforts to achieve interoperability of high-quality in-vitro diagnostic (IVD) test data.  Most notably, the SHIELD Community is a successor from the SHIELD public/private partnership that operated in 2020 and 2021 between health care ecosystem stakeholders and the US Food and Drug Administration (FDA) to produce a Strategic Plan for achieving IVD test data interoperability.  This itself emerged out of multi-agency workshops in 2015 and 2016 and subsequent work efforts.  An urgency for action was created as a result of the challenges faced during the worldwide SARS/COVID-19 pandemic in sharing IVD test data. 

ARTICLE TWO: PURPOSES AND GOVERNING INSTRUMENTS

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To achieve its vision, the SHIELD Community’s mission consists of the following key components:

• Consistent, standards-based identification and description of IVD laboratory data and their attributes which contributes to its semantic harmonization

• Secure, standards-based description of patient information in a manner that allows effective utilization while protecting patient privacy

• Consistent, standards-based interoperability across all applicable information technology systems from the point of order through all downstream uses, both within and between entities in the health care ecosystem

• Understandable, reproducible, and useable results for both human and computerized systems

• Support universal implementation of the above across all entities within the US health care ecosystem

Section 4: Guiding Principles

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In addition, all Organizational Members shall have the following additional rights:

• Selection of a primary representative Primary Delegate to participate in SHIELD Community activities as speaking and voting on the Organizational Member’s behalf

• Selection of a secondary representative Secondary Delegate to participate in SHIELD Community activities as speaking and voting on the Organizational Member’s behalf when the primary representative Primary Delegate is unable to participate

• Permit other personnel affiliated with the Organizational Member to participate in SHIELD Community activities

• Representation of the SHIELD Community in public forums (e.g., professional conferences or webinars)

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• Industry Entity (e.g., EPIC, 3M, Cerner, IMO, Abbott, IICC, Deloitte, Hausam Consulting, EHRA)

• Healthcare Provider (e.g., UTSW, UNMC, Graphite, Indiana University, Tufts University, University of Wisconsin, NACHC, Quest, ACLA)

• Standards Organization (e.g., SNOMED, Regenstrief, HL7)

• Professional Organization (e.g., APHL, CAP, AACC, AMB, AMP)

• Public / Private Partnership (e.g., Reagan-Udall Foundation, MDIC)

• Government Entity - TBD

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Nominations for Membership shall be made by a Member in writing addressed to the organization's Chair and Vice Chair. In addition to being nominated, an organization or individual must also apply in writing. In the case of an Organizational Member, the application must also be signed by a duly authorized representative of the applicant. New Members must be approved by at least a two-thirds (2/3) vote of the Steering CommitteeCommittee’s Voting Representatives.

Section 7: Termination or Withdrawal of Membership

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A Member may be suspended or terminated by the unanimous consent of the Steering Committee Committee’s Voting Members on the good faith determination that the Member in a material or serious degree violated the organization’s charter, or rules of conduct, or has engaged in conduct material and seriously prejudicial to the purposes and interests of the organization.  Termination means that the Member loses its rights and benefits of membership (including rights to participate in any of the activities of the organization such as participation in workgroups) until such time as the Member’s membership is reinstated based on the requirements stated by the Steering Committee.

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ARTICLE FOUR: STEERING COMMITTEE

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As Section 1 is a summarization of SC responsibilities, it will be revisited once Articles Four and Five are completed.

Section 1: Authority and Responsibility

The governing body of the organization shall be the Steering Committee.  The Steering Committee shall:

• Serve as the forum to confirm consensus and document guidance and commitments in the service of the organization's mission

• Determine the organization's strategic policies and changes therein, actively pursue the organization's purposes and objectives and oversee the coordinated delegation of project implementation.

• Vote on nominations of new Members

• Set the number of Voting Representatives and Non-Voting Representatives

• Selecting the Chair and Vice Chair of the Steering Committee

• Establish and select the Leadership of Workgroups

• Vote on other matters that come before the Steering Committee

• Adopt, by unanimous vote, such rules as needed for the conduct of the organization's work

Section 2: Composition of Steering Committee

The Steering Committee shall consist of an odd number of no fewer than thirteen (13) and no more than twenty-one (21) representativesVoting Representatives, who shall be drawn in proportional numbers from the Members of each Stakeholder Category as enumerated in Article Four Section 4 . The with the exception of the Government Entity Stakeholder Category.

In addition to the Steering Committee’s Voting Representatives, up to seven (7) Non-Voting Representatives may be appointed from invited government agencies in an ex officio capacity to serve as liaisons between the SHIELD Community and those agencies.

The Steering Committee shall have the right to increase or decrease the number of Steering Committee seats Voting Members and Non-Voting Members within the above limits by at least a two-thirds (2/3) vote of the Steering Committee Voting Members, provided that any reductions shall take effect coterminous with the expiration of term(s) of existing Steering Committee representatives Representatives of sufficient type and in sufficient numbers to affect such a decrease.

Section 3: Manner of Nomination, Voting, and TermsTerms 

Voting Representatives

Commencing 90 days in advance of an existing Steering Committee representative’s Voting Representative’s term expiring and concluding 30 days in advance of an existing Steering Committee representative’s Voting Representative’s term expiring, nominations from interested Members within the Stakeholder Category of the Steering Committee member whose terms is expiring shall be accepted after such nomination is made by a Member in writing addressed to the organization's Chair and Vice Chair.

Within Subsequently, within 30 days of an existing Steering Committee representative’s Voting Representative’s term expiring, Members whose Stakeholder Category is the same as the Stakeholder Category of the Steering Committee member Voting Representative whose term is expiring shall vote on the nominations that have been received.  The nominee with the most votes in favor shall be confirmed to the expiring seat on the Steering Committee.  .  In the case of a tie, the vote shall be decided by the drawing of lots.

In the case where the terms of multiple Steering Committee representatives’ Voting Representatives within a Stakeholder Category are expiring conterminously, the nominees receiving the most votes in favor sufficient to fill the number of expiring terms shall be confirmed to a seat on the Steering Committee.  In the case of a tie, the confirmation shall be decided by the drawing of lots.

Each representative Voting Representative on the Steering Committee shall hold a seat for a term of three (3) years and may serve up to two consecutive terms.

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Non-Voting Representatives

Non-Voting Representatives shall be nominated by a government agency at the invitation of the Steering Committee.  Such nominations shall then be confirmed by at least a two-thirds (2/3) vote of the Steering Committee’s Voting Representatives as is deemed beneficial to the SHIELD Community’s Vision and Mission for such terms as the Steering Committee prescribes.

Section 4: Conditions

Voting Representatives

The organization shall strive for balance in the constitution of the Steering Committee’s Voting Representatives by attempting to promote equitable representation among the following Stakeholder Categories according to the following percentages:

• Industry Entity – 25%

• Healthcare Provider – 25%

• Standards Organization – 15%

• Professional Organization – 25%

• Public / Private Partnership – 10%

Notwithstanding the above, each Stakeholder Category listed shall be entitled to at least one Voting Representative on the Steering Committee.

Non-Voting Representatives

The organization shall strive for balance in the constitution of the Steering Committee’s Non-Voting Representatives by attempting to promote equitable representation in the selection of Non-Voting Representatives among the various constituencies of federal, state, and local government.  Government agencies from which Non-Voting Representatives are appointed may be Organizational Members of the SHIELD Community but are not required to be so.

Section 5: Resignations

If a Steering Committee Representative is no longer able to serve in that capacity, they shall resign in writing to the organization’s Chair and Vice Chair.

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In the case of a Steering Committee vacancy caused an Organizational Member’s representative Member Delegate’s resignation, the Organizational Member may select a replacement to complete the term of the departing representative Delegate consistent with the rights of an Organizational Member as found in Article 3 Section 2.  Such In the case of a Voting Representative, such a partial term shall not count towards the two term limit in Article Four Section 3.

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An annual meeting of the Steering Committee shall be held once during a calendar year on a date and at such place and/or virtually as the Steering Committee prescribes. Notice of the time, date, and meeting facility of each such meeting shall be given by the Chair or Vice Chair to Members no fewer than thirty (30) days before such meeting.

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Regular meetings of the Steering Committee shall be held at least once a quarter or four (4) times during a calendar year on such dates and at such places and/or virtually as the Steering Committee prescribes. Notice of the time, date, and meeting facility of each such meeting shall be given by the Chair or Vice Chair to Members no fewer than thirty (30) days before such meeting.

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Special meetings of the Steering Committee may be called by the Chair or Vice Chair . Notice of the time, date, place, and purpose of any special meeting of the Steering Committee on such dates and at such places and/or virtually as they prescribe. Notice shall be given by the Chair or Vice Chair to Members no fewer than seven (7) days before such meeting.

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At meetings of the Steering Committee, at least two-thirds (2/3) of the representatives Voting Representatives shall be necessary to constitute a quorum for the transaction of business.

Section 5: Voting Required by Action

Except as otherwise provided in this charter, actions of at least two-thirds (2/3) of the Voting Representatives present during a meeting in which a quorum is present at the time shall be the act of the Steering Committee.

Section 6: Action by Representatives Without a Meeting

Any action required or permitted to be taken at a meeting of the Steering Committee may be taken without a meeting if there is consent in writing or email or other form of electronic transmission, setting forth the action to be taken. A Voting Representative may signify their consent by email or other form of electronic transmission. Such consent shall have the same force and effect as a vote at a meeting duly called. The electronically signed consent, or a signed copy, or a copy of the electronic transmission, shall be filed with the organization's records.

Section 7: Meeting Participation

Unless otherwise determined by the Steering Committee, Steering Committee meeting participation shall be limited to the Voting and Non-Voting Representatives of the Steering Committee.  The Steering Committee may choose to invite non-Steering Committee Members to attend specific Steering Committee meetings, in either an observer or participant capacity, as it deems beneficial.

ARTICLE SIX: NOTICE AND RULES OF ORDER

Section 1: Procedure for Notices

Whenever this charter requires notice to be given, notice shall be given in writing and/or electronically via e-mail or similar method to all Members of the Steering Committee or of the relevant workgroup.

Section 2: Rules of Order

In all matters not covered by this Charter, the SHIELD Community shall be governed by the current edition of Robert’s Rules of Order, the use of which shall be guided through Standing Rules of the SHIELD Committee as may be adopted.

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ARTICLE SEVEN: OFFICERS

Section 1: Number and Qualifications

The executive officers of the organization consist of a Chair and a Vice Chair as determined by the Steering Committee. The Steering Committee may create and establish the duties of such other officers or assistant officers as it deems necessary for the efficient management of the organization.

Section 2: Election and Term of Office

The executive officers shall be elected from among the existing Voting Representatives on the Steering Committee by the Steering Committee Voting Representatives and shall serve for up to two (2) consecutive terms of two (2) years.

Section 3: Removal

Any officer elected by the Steering Committee may be removed by the Steering Committee by three-fourths (3/4) vote whenever in its judgement the best interests of the organization will be served thereby (such as repeated absence from Steering Committee meetings or a failure to fulfill the duties of office).

Section 4: Vacancies

A vacancy in any office arising at any time and from any cause may be filled for the unexpired term at any meeting of the Steering Committee.

Section 5: Chair

The Chair shall preside at all meetings of the Steering Committee, and does not have a vote, except when there is a tie (tie-breaker vote). While serving as Chair, he or she shall continue to represent their organization (in the case of the Chair representing an Organizational Member) or their Stakeholder Category (in the case of the Chair being an Individual Member). The Chair shall perform such other duties and have such other authority and powers as the Steering Committee may prescribe from time to time.

Section 6: Vice Chair

The Vice Chair shall assist and advise the Chair in providing independent and effective leadership. In the absence of the Chair, the Vice Chair shall perform the duties and have the authority to exercise the powers of the Chair. Otherwise, when not acting as the Chair, the Vice Chair may vote on Steering Committee matters. While serving as Vice Chair, he or she shall continue to represent their organization (in the case of the Vice Chair representing an Organizational Member) or their Stakeholder Category (in the case of the Vice Chair being an Individual Member). The Vice Chair shall perform such other duties and have such other authority and powers as the Steering Committee may prescribe from time to time.

ARTICLE EIGHT: WORKGROUPS

Section 1: Workgroups

The Steering Committee may, by at least a two-thirds (2/3) vote, charge and form SHIELD Community workgroups to investigate, deliberate, assess, evaluate, or make recommendations. In no instance shall Steering Committee powers and authority be delegated to a Workgroup.

Section 2: Charges

Workgroup charges shall include the Workgroup's purpose, leadership, objectives, scope, deliverables, timeline, and proposed Member participation.

Section 3: Terms

Workgroups shall expire or sunset after 12 months unless otherwise stated in its charge.

Section 4: Workgroup Leadership

Workgroups shall be led by at least one Member who shall be its Chair, and in the case of multiple Members all shall be deemed equal Co-Chairs.  A Workgroup’s Leadership must include at least one Steering Committee Voting Representative. The Steering Committee shall appoint Workgroup Leadership in consultation with the Membership as part of its charge as defined in Article Eight Section 2.  The Steering Committee shall strive to have equitable representation in the Leadership of the Workgroup as is appropriate for the Workgroup’s charge.

Section 5: Participation

Any Member may choose to participate in a Workgroup.

Section 6: Rules

Workgroups shall make decisions by consensus.  Workgroup Leadership shall determine when consensus has been reached.

Section 7: Confirmation of Critical Workgroup Decisions

For any critical decision, deliverable, standard, position, or the like which a Workgroup has reached consensus, the Workgroup Leadership shall submit same to the Steering Committee for its confirmation.  Once such confirmation is received, the critical decision, deliverable, standard, position, or the like shall be considered to be the official position of the SHIELD Community as a whole.