Last Updated 06 Sep 2022

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/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 test data 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:

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

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

3. 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

4. Understandable, reproducible, and useable results for both human and computerized systems

5. 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

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 representative to participate in SHIELD Community activities as speaking and voting on the Organizational Member’s behalf

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

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.

Section 7: Termination or Withdrawal of Membership

Termination

A Member may be suspended or terminated by the unanimous consent of the Steering Committee 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 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) representatives, who shall be drawn in proportional numbers from the Members of each Stakeholder Category as enumerated in Article Four Section 4.

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

Section 3: Manner of Nomination, Voting, and Terms

Commencing 90 days in advance of an existing Steering Committee representative’s term expiring and concluding 30 days in advance of an existing Steering Committee 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 30 days of an existing Steering Committee representative’s term expiring, Members whose Stakeholder Category is the same as the Stakeholder Category of the Steering Committee member 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 where the terms of multiple Steering Committee 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.

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