SHIELD Community Charter
ARTICLE ONE: ORGANIZATION NAME, TYPE AND HISTORY
Section 1: Name
The name of this organization shall be the "Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD) Community."
Section 2: Type
The organization shall be a voluntary Membership organization that serves only such purposes and functions and shall engage in such activities as are consonant with the purposes set forth in Article Two.
Section 3: History
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-CoV-2/COVID-19 pandemic in sharing IVD test data.
ARTICLE TWO: PURPOSES AND GOVERNING INSTRUMENTS
Section 1: Purpose
The SHIELD Community is an organization of industry, clinical, academic, patient advocacy, standards development, public/private partnership, and professional organization stakeholders working in partnership with government entities with a singular focus on improving the quality, interoperability, and utility of IVD (In Vitro-Diagnostic) test related data and its adoption across the health care ecosystem.
Section 2: Vision
The vision of the SHIELD Community is to enable consistent and uniform communication of high-quality laboratory IVD test data that are computer and human actionable to promote safe, high quality and equitable patient outcomes. In simple words: “Describe the SAME TEST the SAME WAY EVERYWHERE in the health care ecosystem”.
Section 3: Mission
To achieve its vision, the SHIELD Community’s mission consists of the following key components:
Consistent, standards-based identification and description of IVD test related 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
In its operation and deliverables, the SHIELD Community adheres to the following guiding principles:
Committed to Patient Safety
Dedicated to Improving Patient Outcomes
Collaborative in Approach
Integrative in Methodology
Transparent in Activities
Open in Deliverables and Results
Feasible in Recommendations
Focused in Scope
Reduce administrative burden on laboratory and healthcare providers (e.g related to mapping/cross referencing test)
Section 5: Governing Instruments
The organization shall be governed by this charter and its standing rules.
ARTICLE THREE: MEMBERSHIP
Section 1: Classes and Eligibility
There shall be two classes of membership in the organization:
Any organization with mission-critical government, industry, clinical, academic, standards development, professional organization, or similar interests in promoting the cause of the organization as set forth in Article Two may apply for membership as an Organizational Member.
Any individual who has interest in promoting the cause of the organization as set forth in Article Two may apply for membership as an Individual Member. In such capacity, Individual Members shall represent only themselves in their personal capacity without regard to any organization with which they may be an employee or otherwise affiliated.
Section 2: Rights
All Members shall have the following rights in service of achieving and advancing the organization's mission:
Nomination of organizations or individuals for Membership
Vote on matters to which their class of Membership entitles them, as described subsequently in this charter
Serve on the Steering Committee
Serve on SHIELD Community Workgroups
Access to the specifications and standards adopted and promoted by the organization (and its affiliated organizations), and license to the related IP and copyrights, to the extent that it is offered unrestricted in the public domain
In addition, all Organizational Members shall have the following additional rights:
Selection of a Primary Delegate to participate in SHIELD Community activities as speaking and voting on the Organizational Member’s behalf
Selection of a Secondary Delegate to participate in SHIELD Community activities as speaking and voting on the Organizational Member’s behalf when the 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)
Section 3: Voting
Any Member may abstain from participating in a vote.
Section 4: Responsibilities
All Members shall contribute time and expertise to SHIELD Community workgroups, honor their SHIELD Community commitments, solicit opinions from stakeholders, represent their broader field, be responsive to the organization's strategic goals, adhere to the organization’s charter and standing rules, and ensure their attendance and active participation in meetings and Workgroups.
Section 5: Membership Composition
Members shall be drawn from the following stakeholder groups, and each Member shall be categorized as being primarily a representative of one of these Stakeholder Categories:
Industry Entity (e.g., Epic, 3M, Cerner, Abbott, Biomerieux, Roche, IMO, Deloitte, Hausam Consulting, )
Healthcare Provider (e.g., UTSW, UNMC, Graphite, Indiana University, Tufts University, University of Wisconsin, NACHC, Quest, Labcorp) - including physicians, informatians, academia, but clearly identifying the expertise inside this group)
Standards Organization (e.g., SNOMED, Regenstrief, HL7, IICC)
Professional Organization (e.g., ACLA, APHL, CAP, AACC, AMB, EHRA)
Patient Advocacy
Government Entity - (e.g. FDA, ONC, CDC, NIH)
Section 6: Membership Application and Certification
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 Committee’s Voting Representatives.
Section 7: Termination or Withdrawal of Membership
Termination
A Member may be suspended or terminated by the unanimous consent of the Steering 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.
Withdrawal from Membership
A Member may withdraw from the organization at any time by providing written notice to the organization's Chair and Vice Chair.
ARTICLE FOUR: STEERING COMMITTEE
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) Voting Representatives, who shall be drawn in proportional numbers from the Members of each Stakeholder Category as enumerated in Article Four Section 4 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 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 of sufficient type and in sufficient numbers to affect such a decrease.
Section 3: Manner of Nomination, Voting, and Terms
Voting Representatives
Commencing 90 days in advance of an existing Steering Committee Voting Representative’s term expiring and concluding 30 days in advance of an existing Steering Committee 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.
Subsequently, within 30 days of an existing Steering Committee Voting Representative’s term expiring, Members whose Stakeholder Category is the same as the Stakeholder Category of the Steering Committee 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 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 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. Steering Committee members may be nominated again after at least a 1-year hiatus from service.
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 approximately to the following percentages:
Industry Entity – 25%
Healthcare Provider – 30%
Standards Organization – 15%
Professional Organization – 20%
Patient Advocacy - 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.
Section 6: Vacancies
In the case of a Steering Committee vacancy caused an Organizational Member Delegate’s resignation, the Organizational Member may select a replacement to complete the term of the departing Delegate consistent with the rights of an Organizational Member as found in Article 3 Section 2. In the case of a Voting Representative, such a partial term shall not count towards the two term limit in Article Four Section 3.
If the case of a Steering Committee vacancy caused by an Individual Member’s resignation, an election shall be held to complete the term of that Individual Member as described in Article Four Section 3. Such a partial term shall not count towards the two term limit in Article Four Section 3.
ARTICLE FIVE: MEETINGS OF THE STEERING COMMITTEE
Section 1: Annual Meeting
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.
Section 2: Regular Meetings
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.
Section 3: Special Meetings
Special meetings of the Steering Committee may be called by the Chair or Vice Chair 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.
Section 4: Quorum
At meetings of the Steering Committee, at least two-thirds (2/3) of the 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.
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. It is the Chair’s responsibility to manage official correspondence and be the voice of the SHIELD Community or designate another person, when not available.
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. It is the Vice Chair’s responsibility to manage records, minutes and reports.
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.
ARTICLE NINE: AMENDMENTS
Section 1: Power to Amend Charter and Standing Rules
The Steering Committee shall have the exclusive power to alter, amend, or approve this charter. The Steering Committee shall have the power to alter, amend, or approve the standing rules.
Section 2: Conditions
Action by the Steering Committee with respect to the charter and standing rules shall be taken by at least a two-thirds (2/3) vote of all Members present, provided quorum is reached.
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