ATTACH G - Awardable Task Order for BOD Support.pdf

Title: Board of Directors Support IDIQ

RFP No. 75R60224R00009

Attachment G – Awardable Task Order for BOD Support

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TABLE OF CONTENTS

I. BACKGROUND

II. PURPOSE AND PROBLEM STATEMENT

III. PERIOD OF PERFORMANCE/PLACE OF PERFORMANCE

IV. TASKS

1. Services to Support Board of Directors Independence and the Board Nominating Committee

1.1 Special Election/Appointment

1.2 Bylaws and Procedural Updates

1.3 Public Communications

1.4 Nominating Committee Annual Composition Reviews

1.5 Nominating Committee Annual Nomination and Elections Process

1.5.1 Recruitment for the Board of Directors and Executive Committee (EC)

1.5.2 Recruitment for Policy Development Committees and Regions

2. Board of Directors Structural Review

2.1 Board of Director Structure and Composition Review

2.2 Conflicts of Interest

2.2.1 Conflicts of Interests Monitoring and Mitigation Plan

2.2.2 Board of Directors Attestation Forms

2.3 Board of Director Whistleblower

2.4 Member Code of Conduct

2.5 OPTN Final Rule Updates

3. Strategic Planning and Board Development

3.1 Board Orientation

3.1.1 Orientation Materials

3.1.2 Orientation Sessions

3.2 Board Training

3.3 Board Assessment

3.3.1 Board of Directors Performance Monitoring and Risk Mitigation

3.3.2 Board of Directors Continuity Recommendations

3.4 Board Communication

4. Services to Support Board of Director Management Including Membership and Staffing

4.1 Conflict of Interest Monitoring

4.2 Executive Director Process

4.2.1 Executive Director Appointment Process

4.2.2 Executive Director Compensation

4.3 Public Feedback Process

4.4 Support for Board of Directors OPTN Policy and Policy Variance Oversight

4.4.1 OPTN Policy Development Process Plan

4.4.2 OPTN Policies

4.5 Support for Board of Directors Budget Oversight

4.6 Legal Support to the Board of Directors

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4.7 Maintain Rosters

4.8 Charter and Bylaw Maintenance

4.8.1 OPTN Charter

4.8.2 Bylaws, Policies, and Standards for the Operation of the OPTN

5. Administrative Services

5.1 Communications and Information Management

5.2 Program and Project Management Services

5.3 Logistics and Meeting Services

5.4 Document and Records Management

5.5 Document Drafting Services

6. Contract Management

6.1 Branding

6.2 Coordination with Entities Supporting the OPTN

6.3 Kickoff Meeting

6.4 Project Management Plan

6.5 Weekly Conference Calls

6.6 Ad-Hoc Meetings and Alerts

6.7 Quarterly Progress Reports and Contract Meetings

6.7.1 Quarterly Progress Reports

6.7.2 Quarterly Progress Meetings

6.8 Final Report

6.9 Contract Period Briefings .......................................................... Error! Bookmark not defined.

V. SCHEDULE OF DELIVERABLES

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Task Order

Board of Directors Support Task Order

Date: May 1, 2024

I. BACKGROUND

The Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), is the primary federal entity responsible for oversight of organ and blood stem cell transplantation in the United States. HRSA’s Health Systems Bureau’s (HSB) oversees and implements programs and initiatives that increase deceased donation and expand opportunities for living organ donation, with a goal to extend and enhance the lives of individuals with end-stage organ failure for whom an organ transplant is the most appropriate therapeutic treatment. As part of its role, HSB oversees the Organ Procurement and Transplantation Network (OPTN), authorized by the National Organ

Transplant Act of 1984 (NOTA), codified at 42 USC § 273 et seq., and implemented by OPTN regulations (OPTN Final Rule), codified at 42 CFR part 121.

Among its statutory responsibilities, the OPTN shall operate and monitor an equitable system for allocating organs, maintain a waiting list of potential recipients, match potential recipients with donor organs, work to increase the supply of donated organs, and coordinates, as appropriate, the transportation of organs from organ procurement organizations and transplant centers. The OPTN establishes and maintains membership criteria for institutions, individuals, and interested parties, while establishing and maintaining training and experience criteria for designated transplant personnel at transplant programs.

Through committees and the Board of Directors, the OPTN also establishes, maintains, and monitors compliance OPTN policies, including those for the equitable allocation of donor organs among transplant patients.

HRSA’s oversight of the OPTN includes ensuring logistics and management support to the Board of

Directors to fulfill its responsibilities. In addition, HRSA’s oversight is to ensure that the Board of

Directors has the resources and all services necessary to carry out its statutory and regulatory obligations.

II. PURPOSE AND PROBLEM STATEMENT

The purpose of this task order is to obtain all services necessary for the Board of Directors, Board of

Directors designates, and Nominating Committee to effectively carry out their obligations. Board of

Directors designates include the Executive Committee (EC), ad hoc groups, and the Executive Director.

This includes ensuring access to the services necessary to carry out core functions, for example managerial and administrative services, budget and accounting support, legal review and education, risk management, strategic and governance planning, Executive Director recruitment, OPTN policy planning and implementation, managing conflicts of interest, and maintaining the OPTN charter and bylaws.

III. PERIOD OF PERFORMANCE/PLACE OF PERFORMANCE

The period of performance shall be a twelve (12) month base period. The period of performance under this contract shall commence with the effective date of the contract (EDOC). The work shall be performed primarily off-site. All days are calendar unless otherwise noted.

IV. TASKS

1. Services to Support Board of Directors Independence and the Board Nominating Committee

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1.1 Special Election/Appointment

The Contractor shall:

1. Coordinate with HRSA to draft a Special Election/Appointment Plan to seat a new, independent board.

2. Submit the Draft Special Election/Appointment Plan, electronically to the COR for approval within fifteen (15) business days of the EDOC. The Special Election/Appointment Plan shall include:

a) Strategy for election/appointment of new OPTN Board of Directors;

b) Timeframes, including full transition to new Board of Directors within six (6) months of EDOC;

c) Mechanisms for soliciting public input;

d) Criteria and process for seating a transitional nominating committee and timeframes for dissolving the transitional nominating committee;

e) Board of Directors selection criteria, which shall address any actual or potential conflicts of interest.

3. Submit a Final Special Election/Appointment Plan to the COR for approval within seven (7) business days after receipt of COR feedback.

4. Coordinate with HRSA to implement the COR approved Final Special Election/Appointment

Plan.

5. Provide status updates on the plan to the COR during weekly status meetings and Quarterly

Progress Reports and meetings.

1.2 Bylaws and Procedural Updates

1. Coordinate with the newly elected Board of Directors and HRSA to draft a OPTN Bylaws

Update Plan.

2. Submit the Draft OPTN Bylaws Update Plan, electronically to the COR for approval within sixty (60) days of seating a new OPTN Board of Directors. The Draft OPTN Bylaws Update

Plan shall include:

a) Timeframes for reviewing, recommending, and drafting updates to OPTN bylaws and procedures to reflect best practices;

b) The approach to updating Board of Director and OPTN committee nominations and selection processes to ensure the process is:

i) Transparent and fair,

ii) Results in effective recruitment of appropriate expertise, and

iii) Reflects the diverse perspectives of the organ transplant community.

3. Submit a Final OPTN Bylaws Update Plan addressing all COR feedback electronically to the

COR for approval within three (3) business days after receipt of COR feedback.

4. Work with the newly elected Board of Directors and HRSA to implement the OPTN Bylaws

Update Plan, providing all services necessary. The COR shall approve the Plan before implementation.

5. Provide status updates to the COR during weekly status meetings and Quarterly Progress

Reports and meetings.

1.3 Public Communications

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1. Work with HRSA to draft a Public Transparency and Communication Plan for the OPTN

Board.

2. Submit the Public Transparency and Communication Plan, electronically to the COR for approval within thirty (30) business days of the EDOC. The Public Transparency and

Communication Plan shall include:

a) Timeframes and processes for drafting, clearing, and posting public information;

b) Identification of types and approaches to public communication;

c) Evaluation of best methods to ensure ongoing public transparency;

3. Submit a Final Public Transparency and Communication Plan addressing all COR feedback electronically to the COR for approval within three (3) business days after receipt of COR feedback.

6. Work with HRSA and the new OPTN Board to implement the Public Transparency and

Communication Plan, providing all services necessary. The COR shall approve the Plan before implementation.

4. Provide status updates to the COR during weekly status meetings and Quarterly Progress

1.4 Nominating Committee Annual Composition Reviews

The Final Rule includes Board composition requirements.

1. Coordinate with the Nominating Committee to submit a Draft Board of Directors Composition

Review Schedule outlining the deliverables and timeframes for the annual Board of Directors composition review electronically to the COR within ninety (90) days of the EDOC. The

Schedule shall address the timing for, at minimum, the Annual Board of Directors

Composition Review, Board Needs Assessment Report, and Annual Board of Directors

Recruitment Plan, and the associated timeframes for submission of all deliverables to the COR for review, correction, and final approval. If COR requires changes or provides approval of the

Draft, submit a Final Board of Directors Composition Review Schedule electronically to the

COR within five (5) business days after receipt of COR feedback.

2. Coordinate with the OPTN Nominating Committee to conduct an Annual Board of Directors

Composition Review within sixty (60) days of the EDOC to assess whether Board of Directors composition goals meet the requirements described in part 121.3(a)(1) of the OPTN Final Rule and identify disparities in representation to be targeted in the annual Board of Directors nomination process.

3. Submit a Board Needs Assessment Report on the findings of the annual composition review electronically to the COR within ninety (90) days after EDOC for review, correction, and approval in accordance with the Board of Directors Composition Review Schedule. Provide the COR approved Final Needs Assessment report to the OPTN Nominating Committee.

4. Submit a Draft Annual Board of Directors Recruitment Plan based on the Needs Assessment

Report targeting disparities in representation identified in the composition review electronically to the COR within ninety (90) days after EDOC for review, correction, approval, and Final Annual Board of Directors Recruitment Plan in accordance with the Board of

Directors Composition Review Schedule.

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5. Submit the COR approved Final Annual Board of Directors Recruitment Plan to the

Nominating Committee for implementation.

1.5 Nominating Committee Annual Nomination and Elections Process

1.5.1 Recruitment for the Board of Directors and Executive Committee (EC)

The Contractor shall:

1. Coordinate and manage an annual nomination and elections process overseen by the

Nominating Committee to determine members of the Board of Directors as well as a process to select members of the Board of Directors to serve on the EC. The process shall ensure that the Board of Directors and EC meet their compositional requirements as outlined in Sections 121.3(a)(1) and 121.3(a)(2) of the OPTN Final Rule, accordingly.

2. Develop, in coordination with the Board of Directors and Nominating Committee, clear and transparent criteria and process to recruit and nominate individuals, with expertise relevant to the subject matter and work for appointment to the Board of Directors and document the process in the recruitment and nomination process. The recruitment and nomination process shall include:

a) Outreach efforts to stakeholders that are not OPTN members, such as transplant candidates, transplant recipients, living organ donors, and donor family members to encourage participation;

b) Outreach efforts to the broad transplant community;

c) Outreach efforts to the broader clinical community, including clinicians who refer patients for transplant, specialize in medical ethics, or serve pediatric populations

(or other populations as guided by NOTA).

d) Criteria for the selection of members and leadership of all OPTN Operating and

Policy committees;

e) Criteria for the selection of the Board of Directors and leadership published on the

OPTN website;

f) Approach to ensure that the Board of Directors and EC membership is geographically, gender, racially, and ethnically balanced and representative of the diverse community served by the OPTN; and

g) Evaluation and review of the recruiting outcomes to identify potential process improvements, such as participation by all stakeholders, recruiting of new participants to bring new perspectives, and minimizing repeated appointments, unless justified.

3. Submit a Draft Board of Directors and EC Recruitment and Nomination Process electronically to the COR for approval ninety (90) days after EDOC. If the COR requires any changes or approves Draft, submit a Final Board of Directors and EC Recruitment and

Nomination Process to the COR for approval within five (5) business days after receipt of

COR feedback.

4. Provide the COR approved Final Board of Directors and EC Recruitment and Nomination

Process to the Board of Directors for approval.

5. Post the Board of Directors approved Board of Directors and EC Recruiting and

Nominations Process on the OPTN website within ten (10) days after approval by the

Board of Directors.

1.5.2 Recruitment for Policy Development Committees and Regions

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1. Work with the Board of Directors and Nominating Committee to develop and document the OPTN Committees Recruitment and Nomination Process for appointment to OPTN policy committees. The process shall include clear and transparent nomination criteria and recruitment processes that ensure nominated individuals have expertise relevant to the subject matter and work of the committee. The ongoing operations of these committees shall be supported by a separate, OPTN Transition Operations contract. The OPTN

Committees Recruitment and Nomination process shall include:

a) outreach efforts to stakeholders that are not OPTN members, such as transplant candidates, transplant recipients, living organ donors, and donor family members to participate;

b) outreach efforts to the broad transplant community;

c) outreach efforts to the broader clinical community, including clinicians who refer patients for transplant, specialize in medical ethics, or serve pediatric populations

(or other populations as guided by NOTA).

d) criteria for the selection of committee members;

e) criteria for the selection of committee and group leadership (chairs and vice chairs) developed and published on the OPTN website;

f) approach to ensure that committee and regional membership is geographically, gender, racially, and ethnically balanced and representative of the diverse community served by the OPTN; and

g) evaluation and review of the recruiting outcomes to identify potential process improvements in areas, such as participation by all stakeholders, recruiting of new participants, to bring new perspectives, and minimizing repeated appointments, unless justified.

2. Submit a Recruitment and Nomination Process electronically to the COR for approval within ninety (90) days after EDOC. The Recruitment and Nomination Process shall describe the process and criteria for the selection of committee and region members and leadership (i.e., chairs and vice chairs).

3. Submit a Final Recruitment and Nomination Process addressing all COR feedback electronically to the COR for approval within five (5) business days after receipt of COR feedback.

4. Post the recruiting and nominations process on the OPTN website within ten (10) days after approval by the Board of Directors.

5. Maintain rosters of OPTN Committees and Regional leadership, their professional affiliations, and contact information. Publicly post Committee member and Regional leadership names and institutional affiliations, if applicable. Make more detailed contact information available on the Committee or Region internal platforms.

2. Board of Directors Structural Review

2.1 Board of Director Structure and Composition Review

The Contractor shall:

1. Conduct a comprehensive review of the Board of Directors structure and composition requirements with respect to:

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a) NOTA, the OPTN final rule, and OPTN bylaws,

b) Stakeholder feedback,

c) Public input, and

d) Industry best practices.

2. Submit a Structure and Composition Report, electronically to the COR for approval within thirty (30) days of the seating of the new OPTN Board of Directors. The Structure and

Composition Report shall include:

a) Evaluation of the historic and current Board of Directors Structure;

b) Recommendations on the most effective governance structure for the Board of

Directors;

c) Recommendations on the expertise, composition, and size of an effective Board of

Directors;

2.2 Conflicts of Interest

2.2.1 Conflicts of Interests Monitoring and Mitigation Plan

The Contractor shall:

1. Work with the Board of Directors and HRSA to draft an OPTN Conflict of Interest Plan.

2. Submit the OPTN Conflict of Interest Plan, electronically to the COR for approval within thirty (30) days of the new OPTN Board of Directors. The OPTN Conflict of Interest Plan shall include:

a) Definitions of relevant potential and actual conflicts,

b) Processes for monitoring Board of Directors and committee members, if applicable, and

c) Options for members to mitigate the conflict.

3. Submit a Final OPTN Conflict of Interest Plan addressing all COR feedback electronically to the COR for approval within three (3) business days after receipt of COR feedback.

4. Work with the Board of Directors and HRSA to implement the COR approved OPTN

Conflict of Interest Plan, providing all services necessary.

2.2.2 Board of Directors Attestation Forms

1. Work with the Board of Directors and HRSA to draft an OPTN Attestation Plan.

2. Submit the OPTN Attestation Plan, electronically to the COR for approval within 30 days of the new OPTN Board of Directors. The OPTN Attestation Plan shall include:

a) An annual process for members to certify compliance;

b) Standard Attestation Forms for Board of Directors and committee members that require members to:

i) Address conflicts of interest and fiduciary duties to the OPTN, including actual or perceived conflicts of interest,

ii) Acknowledge they shall carry out the responsibilities of the OPTN as authorized by NOTA, OPTN Final Rule, all other applicable laws, regulations, and contractual requirements;

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iii) Follow the OPTN Charter and Bylaws, and work with the OPTN Contractor as it carries out the requirements of the OPTN contract; and

iv) Pledge not to take into consideration any responsibilities they have to any other organizations, as they carry out their Board of Directors responsibilities.

c) Process for ongoing review and reporting on attestation status;

d) Processes for managing and retaining the forms.

3. Submit a Final OPTN Attestation Plan addressing all COR feedback electronically to the

COR for approval within three (3) business days after receipt of COR feedback.

4. Work with the Board of Directors and HRSA to implement the COR approved OPTN

Attestation Plan, providing all services necessary.

2.3 Board of Director Whistleblower

1. Work with the Board of Directors and HRSA to draft a OPTN Whistleblower Protection

Plan.

2. Submit the OPTN Whistleblower Protection Plan, electronically to the COR for approval within 60 days of the new OPTN Board of Directors. The OPTN Whistleblower Protection

Plan shall include:

a) Recommendations based on industry whistleblower and anti-retaliation program best practices;

b) Methods, channels, and systems for submitting, receiving, and monitoring whistleblower complaints;

c) Timeframes and processes for case management and processing complaints;

d) Rules monitoring and ensuring no retaliation;

e) Procedures for processing claims of retaliation and administering any penalties;

f) Standard training and education materials;

g) Approaches to transparency and reporting whistleblower complaints and trends;

3. Submit a Final OPTN Whistleblower Protection Plan addressing all COR feedback electronically to the COR for approval within three (3) business days after receipt of COR feedback.

4. Work with the Board of Directors and HRSA to implement the COR approved OPTN

Whistleblower Protection Plan, providing all services necessary.

2.4 Member Code of Conduct

1. Work with the Board of Directors and HRSA to draft a Member in Good Standing Policy Plan.

2. Submit the Member in Good Standing Policy Plan, electronically to the COR for approval within 60 days of the new OPTN Board of Directors. The Member in Good Standing Policy

Plan shall include:

a) Identifying requirements to be in good standing, including:

i) Completing the annual Attestation Forms and certifications;

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ii) Disclosing new conflicts of interest;

iii) Abstaining from voting or participating on matters where a conflict of interest exists;

iv) Following legal and OPTN policies, including those for whistleblower protections and privacy policies; and

v) Not using information obtained as a member for personal gain;

b) Drafting processes for monitoring member standing;

c) Drafting mitigation and removal processes for Members Not in Good Standing; and

d) Language needed to update OPTN bylaws and policy documents to align with the Plan;

3. Submit a Final Member in Good Standing Policy Plan addressing all COR feedback electronically to the COR for approval within three (3) business days after receipt of COR feedback.

4. Work with the Board of Directors and HRSA to implement the COR approved Member in

Good Standing Policy Plan, providing all services necessary.

2.5 OPTN Final Rule Updates

1. Work with HRSA to draft a Final Rule Update Plan.

2. Submit the Final Rule Update Plan, electronically to the COR for approval within 60 days of the EDOC.

3. Submit a Final Final Rule Update Plan addressing all COR feedback electronically to the COR for approval within three (3) business days after receipt of COR feedback.

4. Work with HRSA to implement the COR approved Final Rule Update Plan, providing all services necessary.

3. Strategic Planning and Board Development

3.1 Board Orientation

3.1.1 Orientation Materials

The Contractor shall:

1. Develop and submit Board of Directors and EC Orientation Materials on OPTN responsibilities to the COR for approval 20 days prior to orientation of new members of the Board of Directors. If the COR requires any changes, submit Final Board of Directors and EC Orientation Materials to the COR for approval within five (5) business days after receipt of COR feedback.

2. Submit Conflict of Interest Educational Materials outlining conflict of interest and attestation requirements for Board of Directors members electronically to the COR for approval at least fifteen (15) business days prior to each orientation meeting. If the COR requires any changes, submit Final Board of Directors and EC Orientation Materials to the

COR for approval within five (5) business days after receipt of COR feedback.

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3.1.2 Orientation Sessions

1. Coordinate orientation sessions, in consultation with the COR, for new Board of Directors members describing their responsibilities to the OPTN and the requirements of NOTA and the OPTN Final Rule. Coordination of orientation sessions includes the mode (virtual or in-person), duration, and the number of orientation sessions for each contract year.

2. Provide the COR approved educational materials to Board of Directors members prior to each orientation session.

3. Ensure the COR, and COR designated government officials, participation in each orientation session.

3.2 Board Training

1. Develop and submit a Legal and Regulatory Education Plan for providing structured education about the legislative and regulatory requirements of NOTA and the OPTN Final Rule to members of the Board of Directors and delegates electronically to the COR for approval within

60 days of the EDOC. The Legal and Regulatory Education Plan shall include, at minimum:

a) approach for development of education content including timelines and milestones;

b) delivery methods;

c) frequency of training;

d) approach for members’ feedback;

e) strategies for new Board of Directors, Board of Directors designates, and Nominating

Committee orientation;

f) refresher training for existing members; and

g) approach for evaluation of effectiveness of educational content and sharing this information with the COR.

2. Submit a Final Legal and Regulatory Education Plan addressing all COR feedback electronically to the COR for approval within five (5) business days after receipt of COR feedback.

3. Implement the COR approved Legal and Regulatory Education Plan.

4. Submit all draft documents developed under the approved plan electronically to the COR for approval in accordance with the Legal and Regulatory Education Plan timelines and milestones.

5. Provide updates on implementation of this plan during weekly conference calls and each

Quarterly Progress Report and meetings.

3.3 Board Assessment

3.3.1 Board of Directors Performance Monitoring and Risk Mitigation

The Contractor shall:

1. Work with the Board of Directors and HRSA to draft a Risk Management Plan.

2. Submit the Risk Management Plan, electronically to the COR for approval within 30 days of the EDOC. The Risk Management Plan shall include:

a) Key performance indicators and quality control measures for OPTN processes;

b) Portfolio risk identification and analysis tools to determine risk likelihood and impact related to Board of Directors operations; and

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c) Creation and management of a risk register.

3. Submit a Final Risk Management Plan addressing all COR feedback electronically to the

COR for approval within three (3) business days after receipt of COR feedback.

4. Work with the Board of Directors and HRSA to implement the COR approved Risk

Management Plan, providing all services necessary.

3.3.2 Board of Directors Continuity Recommendations

1. Work with the Board of Directors and HRSA to draft a Continuity Assurance Plan.

2. Submit the Continuity Assurance Plan, electronically to the COR for approval within 60 days before new OPTN Board of Directors. The Continuity Assurance Plan shall include:

a) A summary of current Board of Directors operations;

b) Identifying critical support activities and key stakeholders;

c) Recommending a knowledge transfer process; and

d) Ensures continuity across Board of Directors members, Executive Directors, and support contractors.

3. Submit a Final Continuity Assurance Plan addressing all COR feedback electronically to the COR for approval within three (3) business days after receipt of COR feedback.

4. Work with the Board of Directors and HRSA to implement the COR approved Continuity

Assurance Plan, providing all services necessary.

3.4 Board Communication

1. Work with the Board of Directors and HRSA to draft a Board Communication Plan.

2. Submit the Board Communication Plan, electronically to the COR for approval within 60 days of the EDOC. The Board Communication Plan shall include:

a) Processes for ensuring the Board of Directors remains informed about OPTN activities;

b) Meeting cadence and participants;

c) Reporting and other forms of communication; and

d) Timeframes for submitting reports or responding to communication requests.

3. Submit a Final Board Communication Plan addressing all COR feedback electronically to the

COR for approval within three (3) business days after receipt of COR feedback.

4. Work with the Board of Directors and HRSA to implement the COR approved Board

Communication Plan, providing all services necessary.

4. Services to Support Board of Director Management Including Membership and Staffing

4.1 Conflict of Interest Monitoring

pg. 13

1. Work with the Board of Directors and HRSA to draft a Conflict of Interest Monitoring Plan.

2. Submit the Conflict of Interest Monitoring Plan, electronically to the COR for approval within

60 days of the EDOC. The Conflict of Interest Monitoring Plan shall include:

a) Monitoring and reporting on Contractor conflicts of interest, including that

Contractor’s Board of Directors remains distinct and separate from OPTN, with no members serving concurrently on Contractor and OPTN Boards;

b) Monitoring Board of Directors membership to track conflicts of interest related to

Board of Directors members serving on the Board of any entity supporting the OPTN through a federal contract, grant or cooperative agreement;

c) Meeting, communication, and reporting requirements related to conflicts of interest and attestations, including public posting of Attestation Forms;

d) Processes for conducting an annual Conflicts of Interest Assessment and routinely mitigating conflicts of interest;

e) Format and requirements for Conflict of Interest Reports; and

f) Timeframes for meetings and submitting Conflict of Interest Monitoring deliverables.

3. Submit a Final Conflict of Interest Monitoring Plan addressing all COR feedback electronically to the COR for approval within three (3) business days after receipt of COR feedback.

4. Work with the Board of Directors and HRSA to implement the COR approved Conflict of

Interest Monitoring Plan, providing all services necessary.

4.2 Executive Director Process

4.2.1 Executive Director Appointment Process

The Contractor shall:

1. Work with the Board of Directors to draft an Appointment Process for the Board of

Directors in recruiting, selecting, compensating, retaining, evaluating performance, and removing the OPTN Executive Director. The appointment process shall:

a) Be objective and measurable;

b) Consider organizational leadership and experience;

c) Consider expertise in the field of organ transplantation;

d) Coordinate a process to modify the OPTN Bylaws, if necessary;

e) Align with the goals of the OPTN, as outlined in the OPTN Strategic Plan;

f) Include approach for the EC to conduct an annual Board of Directors performance review of the OPTN Executive Director on behalf of the Board of Directors; and

g) Include approaches for determination of reappointment of the OPTN Executive

Director.

2. Provide administrative and management services necessary for the Executive Director to perform their responsibilities. The Executive Director has the following responsibilities:

a) Coordination of the activities of the permanent operating committees;

b) Maintenance of the current list of names and addresses of the Board of Directors;

and

c) Retention of the financial records of the OPTN and accounts for the revenues and expenses of the OPTN.

pg. 14

3. Submit the Appointment Process electronically to the COR for approval within 30 days after the EDOC.

4. Coordinate with the Board of Directors to review the Appointment Process annually.

5. Submit any updates to the Appointment Process electronically to the COR for approval within 30 days after the annual review and within 30 days before any additional updates beyond those completed as part of the annual review.

6. If the COR requires any changes, submit the revisions electronically to the COR within three (3) business days after receipt of COR feedback.

7. Implement COR approved Appointment Process.

8. Provide the name(s) and qualifications (e.g., curriculum vitae) of the proposed OPTN

Executive Director electronically to the COR for review at least 30 days before the Board of Directors review and appointment process.

9. Submit a summary of the annual evaluation of the Executive Director’s performance to the full Board of Directors and the COR for review 30 days before the Board of Directors’ decision regarding reappointment.

10. Update the OPTN Bylaws to document the roles and responsibilities of the OPTN

Executive Director as necessary.

4.2.2 Executive Director Compensation

1. Submit to the COR a Compensation Plan for approval within 45 days after the EDOC. The plan shall include:

a) the annual cost for compensating the Executive Director using contract funds, not to exceed the HHS salary cap;

b) the administrative processes for managing compensation; and

c) conflict of interest procedures.

2. Submit a Final Compensation Plan addressing all COR feedback electronically to the COR for approval within three (3) business day after receipt of COR feedback.

3. Provide all services required to implement the COR approved plan.

4.3 Public Feedback Process

1. Work with the Board of Directors and HRSA to draft a Public Feedback Plan.

2. Submit the Draft Public Feedback Plan, electronically to the COR for approval within 60 days of the EDOC. The Public Feedback Plan shall include:

a) Process to regularly solicit public feedback on OPTN priorities and projects;

b) Methods, modes, and systems for submitting and receiving public feedback;

c) Plan for outreach to publicize process for submitting public feedback and community input;

d) Approach to ensuring feedback is incorporated into annual planning;

e) Reporting and monitoring requirements; and

f) Timeframes for implementing or submitting Public Feedback deliverables.

3. Submit a Final Public Feedback Plan addressing all COR feedback electronically to the COR for approval within three (3) business days after receipt of COR feedback.

4. Work with the Board of Directors and HRSA to implement the COR approved Public

Feedback Plan, providing all services necessary.

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4.4 Support for Board of Directors OPTN Policy and Policy Variance Oversight

4.4.1 OPTN Policy Development Process Plan

The Contractor shall:

1. Submit a Draft OPTN Policy Development Process Plan electronically to the COR for approval within 90 days of the EDOC. All policies developed by the OPTN and approved by the Board of Directors are OPTN policies. The OPTN Policy Development Process

Plan shall cover the policies the OPTN shall develop and send for approval by the Board of

Directors.

2. Include in the OPTN Policy Development Process Plan activities to support the Board of

Directors and OPTN policy development committees in developing, documenting, maintaining, and refining evidence based OPTN policies in accordance with the requirements of NOTA, the OPTN Final Rule, the OPTN contract, and other applicable federal laws and regulations. At a minimum, the OPTN Policy Development Process Plan shall include:

a) Process map and checklists to assist the Board of Directors and governance groups in documenting the deliberation involved to ensure that proposed OPTN polices comply with requirements of NOTA and the OPTN Final Rule, including the involvement of critical OPTN constituencies;

b) Timeline for COR review, comment, and approval of all proposed policy projects, all policy proposals, Requests for Information, and Board of Directors briefing documents;

c) How ethical issues in organ procurement and transplantation shall be addressed;

d) Discussion of fiscal impacts of new policies on both the OPTN and OPTN members;

e) Approach for assessing operational impacts of new policies prior to implementation;

f) Approach for post-implementation assessment to ensure policies meet their intended objectives;

g) Process for involving representatives from critical constituencies with an interest in donation and transplantation, including organ procurement professionals, transplantation coordinators, transplant center administrators, deceased donor families, living donors, transplant recipients, and candidates waiting for transplant;

h) Process to collect and consider comments from OPTN members, experts in pediatric transplant, minority, vulnerable populations, and the public consistent with the requirements of the OPTN Final Rule (42 CFR § 121.4(b)(1)); and

i) Process for guaranteeing HRSA reviews all proposed policies or policy changes to ensure they conform with NOTA and OPTN Final Rule requirements.

3. Submit a Final Policy Development Process Plan addressing all COR feedback electronically to the COR for approval within five (5) business days after receipt of COR feedback.

4. Provide the services for OPTN to implement the COR approved Final Policy Development

Process Plan.

pg. 16

5. Publish the COR approved Final Policy Development Process plan on the OPTN website within ten (10) business days of COR approval.

6. Publish any updates to the Policy Development Process Plan on the OPTN website within ten (10) business days of COR approval.

4.4.2 OPTN Policies

1. Submit to the COR within 90 days after EDOC, all policy proposals, Requests for

Information, and Board of Directors briefing documents in accordance with the timelines established in the Final Policy Development Process Plan and any timelines specific to the policy development process plan electronically to the COR for review, comment, and approval, all proposed policy projects for the OPTN.

2. Ensure materials submitted demonstrate OPTN governance group and Board of Directors deliberation and rationale for finding that proposed policies meet NOTA and OPTN Final

Rule requirements in all proposed policy or policy change proposals, and a written explanation of how the proposal meets or improves compliance with the requirements of

NOTA and the OPTN Final Rule.

3. Publish a list of all approved OPTN Bylaws and policies, including all variances, and the

Board of Directors approval and implementation dates (or proposed implementation date) for all approved OPTN policies on the OPTN website within five (5) business days after

Board of Directors approval.

4.5 Support for Board of Directors Budget Oversight

1. Coordinate with the Board of Directors and HRSA to draft a Budget Oversight Plan.

2. Submit the Draft Budget Oversight Plan, electronically to the COR for approval within 90 days of the EDOC. The Budget Oversight Plan shall include:

a) Processes to ensure Board of Directors understanding of OPTN budget and finance materials;

b) Controls, processes, and procedures for the Board of Directors to validate OPTN financial and budget documents and statement;

c) Metrics, reporting capabilities, and solutions for the fiscal management of the OPTN;

d) Approach for ensuring Board of Director access to finance and budget expertise;

e) Strategy for Board Support Contractor serving as Board of Director liaison with other

OPTN components and contractors; and

f) Timeframes for meeting Budget Oversight Plan requirements.

3. Submit a Final Budget Oversight Plan addressing all COR feedback electronically to the COR for approval within three (3) business days after receipt of COR feedback.

4. Coordinate with the Board of Directors and HRSA to implement the COR approved Budget

Oversight Plan.

4.6 Legal Support to the Board of Directors

pg. 17

1. Coordinate with the Board of Directors and HRSA to draft a Legal Support Plan.

2. Submit the Draft Legal Support Plan, electronically to the COR for approval within 90 days of the EDOC. The Legal Support Plan shall include:

a) Approach to ensure OPTN activities including policy decisions and operations comply with NOTA, the OPTN Final Rule, the OPTN contract and other applicable Federal laws and regulations;

b) Plan for submitting any legal decision or advice regarding OPTN policies or operations, including submission to the COR for review;

c) Plan for ensuring Board of Director access to legal support;

d) Timeframes for meeting Budget Oversight Plan requirements; and

e) Legal support for the maintenance of OPTN entity’s private non-profit status.

3. Submit a Final Legal Support Plan addressing all COR feedback electronically to the COR for approval within three (3) business days after receipt of COR feedback.

4. Coordinate with the Board of Directors and HRSA to implement the COR approved Final

Legal Support Plan, providing all services necessary.

4.7 Maintain Rosters

1. Maintain rosters of members of the Board of Directors and EC, their professional affiliations, contact information, and indication of their Board of Directors compositional category (as described in Sections 121.3(a)(1) and (a)(2) of the OPTN Final Rule).

4.8 Charter and Bylaw Maintenance

4.8.1 OPTN Charter

1. Conduct a yearly review of the OPTN Charter to ensure that the OPTN Charter is up to date; includes all aspects of OPTN structure and operations; and aligns with federal laws, OPTN policies, and contract requirements.

2. Submit all proposed OPTN charter updates to the COR for approval at least 30 days prior to sending the updates to the Board of Directors for approval. If the COR requires any changes, submit revisions electronically to the COR within three (3) business days after receipt of COR feedback.

3. Submit COR approved OPTN charter updates to the Board of Directors for review and approval.

4. Post the COR approved OPTN charter to the OPTN website no later than ten (10) days after approval by the Board of Directors.

4.8.2 Bylaws, Policies, and Standards for the Operation of the OPTN

1. Review, manage, and maintain bylaws, policies, and standards governing the operations of the OPTN and ensure they are up-to-date and consistent with federal laws, OPTN policies,

pg. 18 and contract requirements. Proposed updates to bylaws, policies, and standards governing the operations of the OPTN shall go through the Board of Directors for approval.

2. Submit all Board of Directors or EC Action Documentation, including draft policy projects, public comment proposals, and briefing documents for the Board of Directors or

EC addressing changes to the OPTN bylaws policies to the COR for review 30 days in advance of board’s review.

5. Administrative Services

5.1 Communications and Information Management

The Contractor shall:

1. Submit to the COR a Draft Communication Management Plan for approval within 90 days after the EDOC. The plan shall include:

a) Ensuring coordination, information transfer, and seamless communication across the

OPTN, HRSA, HRSA contractors, and other entities supporting the OPTN, including:

i) ensuring the Board of Directors, Board of Directors designates, and Nominating

Committee are routinely informed about Board of Directors and OPTN-wide activities,

ii) processes for requesting and receiving information from OPTN components at the request of the Board of Directors, Board of Directors designates, and

Nominating Committee;

b) Ensuring coordination with OPTN entities responsible for collaboration, document sharing, and email platforms to support access and ease of use for the Board of

Directors, Board of Directors designates, and Nominating Committee;

c) Compiling, consolidating, and summarizing information requested by the Board of

Directors, Board of Directors designates, and Nominating Committee, including managing branding of OPTN materials and messaging;

d) Ensuring coordination with OPTN entities responsible for communications and web posting to facilitate Board of Directors, Board of Directors designates, and Nominating

Committee updates and communications; and

e) Providing an External Summary that highlights the most significant themes and trends in OPTN related public information to the COR and the Board of Directors, or their designates.

2. Submit a Final Communication Management Plan addressing all COR feedback electronically to the COR for approval within three (3) business day after receipt of COR feedback.

3. Implement the COR approved plan.

5.2 Program and Project Management Services

1. Coordinate with the Board of Directors and HRSA to draft a Project Management Services

Plan.

2. Submit the Draft Project Management Services Plan, electronically to the COR for approval within 45 days of the EDOC. The Project Management Services Plan shall include:

a) Processes for receiving incoming project management support requests;

pg. 19

b) Creating and maintaining project schedules that include lists of all tasks/milestones, timescales, and metrics for successful delivery for assigned projects;

c) Communication plans defining how and when project communications shall take place, including addressing communication needs for all audiences impacted by the project;

d) Plan for determining stakeholder engagement for each project, including criteria for determining audiences, communication modes and methods, and minimum communication timeframes;

e) A task tracking system that is capable of monitoring, reporting, and archiving all assigned tasks, including functionalities for setting due dates, prioritizing tasks to specific individuals or teams, and alerting for overdue tasks; and

f) Creation and maintenance of risk registries.

3. Submit a Final Project Management Services Plan addressing all COR feedback electronically to the COR for approval within three (3) business days after receipt of COR feedback.

4. Coordinate with the Board of Directors and HRSA to implement the COR approved Final

Project Management Services Plan, providing all services necessary.

5.3 Logistics and Meeting Services

1. Ensure transparency in Board of Directors and Nominating Committee deliberations. This includes, at a minimum, ensuring that:

a) All meetings not identified as closed are open and accessible to the public;

b) For closed sessions, there is a clear and specific justification for not being open to the public and shall be approved by HRSA; and

c) Regardless of whether the meeting is open or closed to the public, HHS representatives designated by the COR are invited and allowed to attend.

2. Submit to the COR an administrative and logistical support Draft Annual Meeting Plan for approval within 90 days after the EDOC. The plan should anticipate up to two (2) in-person meetings with a virtual capabilities for the Board of Directors annually and up to six (6) ad hoc virtual meetings annually. In addition, the plan shall anticipate an average of three (3) virtual ad hoc and work group meetings for the Executive Committee, Executive Director, and

Nominating Committee per month. The Annual Meeting Plan shall include at minimum:

a) Designated point of contact/liaison for the Board of Directors, Executive Committee, and Nominating Committee;

b) Criteria for closed sessions of the Board of Directors meetings;

c) Plan for holding meetings publicly in open sessions;

d) Frequency (dates and time with clear justifications) and mode (virtual or in person with clear justifications). Meetings shall not be held on Federal holidays or weekend days

(Saturday and Sunday);

e) Plan for hybrid meetings that includes:

i) locations of hybrid meetings based on the following criteria:

1) ease of access (location proximal to a major airport hub and accessible from any part of the United States), including access to hotel space, and public transportation and parking,

pg. 20

2) non-luxury or upper-class properties (hotel and meeting space) based on public hospitality benchmarking organizations,

3) per diem rate for the properties at or below the federal per diem rates for travelers, and

4) acceptance of federal per diem reimbursement rates for travelers;

ii) structure and process to support and facilitate travel of all non-Federal members attending in-person meetings;

f) Timelines for developing relevant materials including agenda for each meeting and sharing them with the relevant group. Meeting package including agenda shall be sent to all members at least fifteen (15) calendar days prior to each in-person meeting, and ten (10) days prior to each virtual meeting;

g) Approach for responding to data requests based on questions asked by the Board of

Directors as part of their evidence gathering process. Response to formal data requests shall be made in coordination with the SRTR Contractor and the appropriate HRSA representatives;

h) Timelines for making meeting summaries available. Meeting summaries shall be sent electronically to the COR within two (2) business days after each meeting and within five (5) business days to the relevant Board of Directors, Board of Directors designates, or Nominating Committee. The meeting summaries shall include topics covered, decisions considered and made by the committee, and required follow-up actions including responsible parties; and

i) Process and timeline for coordinating with other OPTN entities responsible for communications, records archiving, and hosting virtual meeting platforms, including procedures for collaboration on:

i) approach and timeline for advance notification to the public, including information on public access to the meeting;

ii) posting information such as meeting announcements and meeting summaries on the OPTN website (Board of Directors meeting announcements and summaries shall only contain information relating to activities of the OPTN); and

iii) ensuring appropriate usage of OPTN logo and OPTN correspondence templates for all meeting materials and publications;

iv) plan for recording and transcribing all Board of Directors meetings and retaining recordings for the duration of the contract and for providing these materials to the COR after each event, as well as at the end of the contract for records management purposes;

v) accommodation for individuals with hearing, visual, and physical impairment as well as individuals in need of interpretation or translation services;

3. Submit a Final Annual Meeting Plan addressing all COR feedback electronically to the COR for approval within five (5) business day after receipt of COR feedback.

4. Provide administrative and logistical support in accordance with the COR approved Annual

Meeting Plan.

5. Submit updates electronically to the COR as changes occur to the Annual Meeting Plan.

5.4 Document and Records Management

pg. 21

1. Submit to the COR a Records Management Plan for approval within 90 days after the EDOC.

The plan shall include:

a) Facilitating retention,…