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Last Updated 24 Oct 2022 28 Feb 2023

This page was LOCKED for editing AFTER the ALL SHIELD call on February 28th, 2023 - the text content will be copied into 2 pages, one for the charter and one for the Standing Rules prior to Steering Committee Vote on March 7th, 2023.

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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-CoV-2/COVID-19 pandemic in sharing IVD test data. 

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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”.

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• Consistent, standards-based identification and description of IVD laboratory 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

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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., EPICEpic, 3M, Cerner, IMO, Abbott, IICCBiomerieux, Roche, IMO, Deloitte, Hausam Consulting, EHRA )

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

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

• Patient Advocacy

• Government Entity - TBD(e.g. FDA, ONC, CDC, NIH)

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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

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• Industry Entity – 25%

• Healthcare Provider – 25%30%

• Standards Organization – 15%

• Professional Organization – 25%Public / Private Partnership – 20%

• Patient Advocacy - 10%

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

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The proceedings of the Steering Committee shall be available to all Members. Steering Committee meeting summaries should be accessible for viewing on the organization's website within 14 days of convening regular or special meetings and within 30 days of convening an annual meeting. Notifications of meeting summaries should be communicated to audiences through the organization's electronic newsletter or other similar push delivery method.. Meetings will be recorded to support accuracy of decisions and detailed discussions in the minutes and not posted publicly. 

Rule II. Steering Committee Meeting Agenda

Steering Committee meetings shall be structured to focus on critical decisions. The Chair or Vice Chair will distribute meeting agendas and related materials no less than 5 business days in advance.

Information on subjects that per the Charter do not require a vote will be provided in writing before meetings. These subjects will then appear in the meeting agenda within a consent agenda consisting of information that will be discussed only if a Steering Committee Voting Representative requests a discussion and will otherwise stand as pro forma acceptance by the governance body.

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Whenever an Organizational Member, Organizational Member Delegate, or Individual Member has a financial or personal interest in any matter coming before the Steering Committee or Workgroup, the affected person shall a.) fully disclose the nature of the interest and b.) withdraw from discussion, lobbying, and voting on the matterconflict of interest as part of a declaration for each Steering Committee member on file. Any transaction or vote involving a potential conflict of interest shall be approved only when a majority of disinterested Members determine that it is in the best interest of the organization to do so. The minutes of meetings at which such votes are taken shall record such disclosure, abstention and rationale for approval.

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Rule V. Representing SHIELD Community

Any SHIELD member should provide advance notice, as soon as possibleto the Chair and Vice Chair of any public speeches, presentations, where it may be beneficial to represent SHIELD in an official capacity.

Any member planning a presentation or talk about the work of  the SHIELD Community should share presentation material

in advance with the Steering Committee Chair to ensure it is up to date. Once such representations are made, the given member should report at minimum the title, speakers, and an audience characterization to the Vice-Chair for tracking purposes, but ideally share the slides.

Rule VII: Antitrust

Although a collaborative organization such as the SHIELD Community is recognized as a valuable forum for advancing the goals of the health care ecosystem, one of the potential dangers which participants of any organization face is compliance with federal and state antitrust laws.  Such laws generally forbid any combination, contract or conspiracy that restrains trade. Since by its nature SHIELD Community Members may be competitors in the course of their normal business, all SHIELD Community Members must ensure that their activities do not violate applicable law.

The following activities are among those that have been held to be per se illegal under the antitrust laws:

 ·       Agreements to fix prices, regardless of whether prices are increased, decreased, stabilized, or set according to an agreed formula or subject to uniform discounts or allowances, including topics that might indirectly affect prices, such as costs, discounts, profit levels, pricing procedures, credit terms, or control of sales

·       Agreements to divide or allocate territories or customers

·       Agreements not to deal with a particular customer or supplier or group of customers or suppliers

 SHIELD Community Members must refrain from any discussion that could be interpreted as being in restraint of trade. 

Rule VIII: Application of Rules of Order

The following Standing Rule clarifies how the SHIELD Community shall use Robert’s Rules of Order in the conduct of its business, specifically in the holding of Steering Committee and Workgroup meetings.

Guiding Principles

The following guiding principles are meant to ensure that all Members are heard and that any debate, question or vote can be conducted as fairly as possible.

 ·       Each Steering Committee or Workgroup meeting should follow an order of business called an agenda. Everything on the agenda is reviewed in its order and disposed of before Members proceed to the next item.

·       All Members have equal rights, privileges and obligations. Everyone has the right to be heard. No Member speaks twice about a motion until all Members have had the opportunity to speak.

·       Only one item of business or question can be taken up at any time. This provides the opportunity for a full and fair discussion, dissuades topic tangents, and maintains order.

·       The majority vote rules. However, this doesn’t mean the rights of every individual are not protected.

·       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

Within Robert’s Rules of Order, there are numerous definitions and fundamentals to remember. Below are definitions for some of the most common and important terms.

Motion

A motion is a formal proposal by a Member of the Steering Committee or Workgroup. In simple terms, they can help form decision-making processes. Usually, this starts with the phrase “I move”. This then opens the ‘motion’ up for debate and discussion.

Second

To ‘second’ a motion means that another Member of the Steering Committee or Workgroup agrees with the motion and would also like for it to be considered. “I second the motion”.

Amendment

An amendment is an alteration of a motion statement. It can be added to a motion before it can be voted on. There are a few ways it can be amended, such as:

 ·       removing words

·       adding words

·       swapping words (i.e., removing a word and adding a new word in its place)

·       substituting a paragraph for another

 A motion cannot be amended by simply rejecting it.

Quorum

A quorum is the minimum number of Members who need to be present for any business to be conducted in the name of the Steering Committee or Workgroup. It is not possible to take votes on business unless the prescribed quorum is present.

Roles

Presiding Officer

As applicable, the Chair, Vice Chair, or Co-Chair of the Steering Committee or Workgroup shall serve as the Presiding Officer for a meeting in which they lead.  The Presiding Officer must be present at the meeting. It is their job to lead the meetings, but they cannot debate or submit their own motion.

The Presiding Officer should:

 ·       Set the goals for the meeting, discussion, or vote

·       Be and remain impartial and neutral

·       Take and remain in control of the meeting

·       Ensure that the rights of all Members are protected

·       Not take part in motions, debates or votes (except as stipulated in the Charter)

The responsibilities of the Presiding Officer throughout the meeting include:

·       Opening the session by announcing the purpose and topic of the meeting, as well as calling Members to order

·       Recognizing the Members to speak and giving them ‘the floor’

·       Facilitating and announcing the results of any votes

·       Keeping disruptions and distractions to a minimum

·       Keeping the direction of the meeting on the topic according to the agenda

·       Protecting the ‘minority’ from any disruptive behavior from the majority

·       Designating a Secretary at the beginning of each meeting

Secretary

The Secretary must be present at the meeting.

 The responsibilities of the Secretary throughout the meeting include:

·       Taking minutes as a record of the meeting, submitting them for approval, and publishing them when approved

·       Preparing the agenda, order of business, and relevant notes for the Presiding Officer

·       Keeping the Charter, Standing Rules, and prior minutes for reference to support the Presiding Officer as needed

The Presiding Officer may choose to designate themselves as the Secretary.

Parliamentarian

The Presiding Officer shall designate a Parliamentarian at the beginning of each meeting in which they lead.  The Parliamentarian must be present at the meeting.

The responsibilities of the Parliamentarian throughout the meeting include:

·       Assisting the Presiding Officer to ensure that discussions and actions taken during the meeting follow the Rules of Order as prescribed in Article Six Section 2

·       Having the final authority on all points of order raised during the meetingshall not speak or publish on behalf of the SHIELD community without approval of the Steering Committee Chair.

Rule VI. Intellectual Property

Consistent with its Purpose as stated in Article One Section 1 and the Guiding Principle “Open in Its Deliverables and Results” in Article Two Section 4, the SHIELD Community requires that all contributions to the SHIELD community and all distributions from the SHIELD Community must be compatible with the Creative Commons Attribution 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/ or send a letter to Creative Commons, PO Box 1866, Mountain View, CA 94042, USA.

Rule VII: Antitrust

Although a collaborative organization such as the SHIELD Community is recognized as a valuable forum for advancing the goals of the health care ecosystem, one of the potential dangers which participants of any organization face is compliance with federal and state antitrust laws.  Such laws generally forbid any combination, contract or conspiracy that restrains trade. Since by its nature SHIELD Community Members may be competitors in the course of their normal business, all SHIELD Community Members must ensure that their activities do not violate applicable law.

The following activities are among those that have been held to be per se illegal under the antitrust laws:

 ·       Agreements to fix prices, regardless of whether prices are increased, decreased, stabilized, or set according to an agreed formula or subject to uniform discounts or allowances, including topics that might indirectly affect prices, such as costs, discounts, profit levels, pricing procedures, credit terms, or control of sales

·       Agreements to divide or allocate territories or customers

·       Agreements not to deal with a particular customer or supplier or group of customers or suppliers

 SHIELD Community Members must refrain from any discussion that could be interpreted as being in restraint of trade. 

Rule VIII: Application of Rules of Order

The following Standing Rule clarifies how the SHIELD Community shall use Robert’s Rules of Order in the conduct of its business, specifically in the holding of Steering Committee and Workgroup meetings.

Guiding Principles

The following guiding principles are meant to ensure that all Members are heard and that any debate, question or vote can be conducted as fairly as possible.

 ·       Each Steering Committee or Workgroup meeting should follow an order of business called an agenda.

·       All Members have equal rights, privileges and obligations. Everyone has the right to be heard. No Member speaks twice about a motion until all Members have had the opportunity to speak.

·       Only one item of business or question can be taken up at any time. This provides the opportunity for a full and fair discussion, dissuades topic tangents, and maintains order.

·       The majority vote rules. However, this doesn’t mean the rights of every individual are not protected.

·       The Steering Committee or Workgroup may reserve the right to identify a particular item as requiring consensus rather than the 2/3 majority vote.

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Definitions

Within Robert’s Rules of Order, there are numerous definitions and fundamentals to remember. Below are definitions for some of the most common and important terms.

Motion

A motion is a formal proposal by a Member of the Steering Committee or Workgroup. In simple terms, they can help form decision-making processes. Usually, this starts with the phrase “I move”. This then opens the ‘motion’ up for debate and discussion.

Second

To ‘second’ a motion means that another Member of the Steering Committee or Workgroup agrees with the motion and would also like for it to be considered. “I second the motion”.

Amendment

An amendment is an alteration of a motion statement. It can be added to a motion before it can be voted on. There are a few ways it can be amended, such as:

 ·       removing words

·       adding words

·       swapping words (i.e., removing a word and adding a new word in its place)

·       substituting a paragraph for another

 A motion cannot be amended by simply rejecting it.

Quorum

A quorum is the minimum number of Members who need to be present for any business to be conducted in the name of the Steering Committee or Workgroup. It is not possible to take votes on business unless the prescribed quorum is present.

Roles

Presiding Officer

As applicable, the Chair, Vice Chair, or Co-Chair of the Steering Committee or Workgroup shall serve as the Presiding Officer for a meeting in which they lead.  The Presiding Officer must be present at the meeting. It is their job to lead the meetings, but they cannot debate or submit their own motion.

The Presiding Officer should:

 ·       Set the goals for the meeting, discussion, or vote

·       Be and remain impartial and neutral

·       Take and remain in control of the meeting

·       Ensure that the rights of all Members are protected

·       Not take part in motions, debates or votes (except as stipulated in the Charter)

The responsibilities of the Presiding Officer throughout the meeting include:

·       Opening the session by announcing the purpose and topic of the meeting, as well as calling Members to order

·       Recognizing the Members to speak and giving them ‘the floor’

·       Facilitating and announcing the results of any votes

·       Keeping disruptions and distractions to a minimum

·       Keeping the direction of the meeting on the topic according to the agenda

·       Protecting the ‘minority’ from any disruptive behavior from the majority

·       Designating a Secretary at the beginning of each meeting

Secretary

The Secretary must be present at the meeting.

 The responsibilities of the Secretary throughout the meeting include:

·       Taking minutes as a record of the meeting, submitting them for approval, and publishing them when approved

·       Preparing the agenda, order of business, and relevant notes for the Presiding Officer

·       Keeping the Charter, Standing Rules, and prior minutes for reference to support the Presiding Officer as needed

The Presiding Officer may choose to designate themselves as the ParliamentarianSecretary.

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Parliamentarian

The motion is the main topic that is being discussed, with no other motions pending. A motion:

·       Requires a second for the motion

·       Is debatable

·       May be reconsidered

·       Is amendable

·       Requires a vote (a two-thirds vote to form a majority to pass the motion, unless otherwise prescribed in the Charter)

Voting

After debate and discussion have been had and no one else has risen to take the floor, the voting process can begin.

Unanimous Consent

Unanimous consent may be used to expedite the discussion and the debate process on topics in which most Members are in agreement.

·       Only the Presiding Officer may move to vote directly in this way. Instead of opening up a topic for debate, the Presiding Officer may say “If there is no objection, [subject] is approved.”

·       In the case where some members do want to open up the discussion before voting, any member may say “I object” prior to the vote. Then, the Presiding Officer must open up the discussion and get votes from both sides of the debate.

·       Officers can also clarify those for and against the motion quickly with a show of hands. If it is clear that everyone is for or everyone is against the motion, the Presiding Officer can ask for an opposition speaker. If there isn’t anyone who wants to speak for the opposition, then they can ask to move directly to the vote.

Source

Adapted from iBABS Robert’s Rules of Order: Simplified Beginner’s Guide - https://www.ibabs.com/en/roberts-rules-of-order/complete-guide/

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These rules are still being discussed:

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Presiding Officer shall designate a Parliamentarian at the beginning of each meeting in which they lead.  The Parliamentarian must be present at the meeting.

The responsibilities of the Parliamentarian throughout the meeting include:

·       Assisting the Presiding Officer to ensure that discussions and actions taken during the meeting follow the Rules of Order as prescribed in Article Six Section 2

·       Having the final authority on all points of order raised during the meeting

The Presiding Officer may choose to designate themselves as the Parliamentarian.

Motions

The motion is the main topic that is being discussed, with no other motions pending. A motion:

·       Requires a second for the motion

·       Is debatable

·       May be reconsidered

·       Is amendable

·       Requires a vote (a two-thirds vote to form a majority to pass the motion, unless otherwise prescribed in the Charter)

Voting

After debate and discussion have been had and no one else has risen to take the floor, the chair will call the question and the voting process can begin.

Unanimous Consent

Unanimous consent may be used to expedite the discussion and the debate process on topics in which most Members are in agreement.

·       Only the Presiding Officer may move to vote directly in this way. Instead of opening up a topic for debate, the Presiding Officer may say “If there is no objection, [subject] is approved.”

·       In the case where some members do want to open up the discussion before voting, any member may say “I object” prior to the vote. Then, the Presiding Officer must open up the discussion and get votes from both sides of the debate.

·       Officers can also clarify those for and against the motion quickly with a show of hands. If it is clear that everyone is for or everyone is against the motion, the Presiding Officer can ask for an opposition speaker. If there isn’t anyone who wants to speak for the opposition, then they can ask to move directly to the vote.

Source

Adapted from iBABS Robert’s Rules of Order: Simplified Beginner’s Guide - https://www.ibabs.com/en/roberts-rules-of-order/complete-guide/