HRSA OPTN Industry Day Slides - Nov 2023.pdf

OPTN MODERNIZATION

OPTN Board Support Contract Industry Day

November 9, 2023

• Suma Nair, Associate Administrator, Health Systems Bureau

• Alexandra “Bonnie” Garcia, HRSA Head of Contracting Activity

• Manjot Singh, OPTN Modernization Lead, Health Systems Bureau

Welcome Alexandra “Bonnie” Garcia, HRSA Head of Contracting Activity

• Shared information on OPTN modernization and preliminary transition contract approach with 300+ businesses, non-profits, academic institutions, and patient advocates

• Presentation and related materials:

https://sam.gov/opp/31973befa4de49a8a41f5 db99f516d40/view#general

• List of attendees available on HRSA’s

FOIA Electronic Reading Room.

https://www.hrsa.gov/foia/electronic-reading

JULY 2023 – INDUSTRY DAY

https://sam.gov/opp/31973befa4de49a8a41f5db99f516d40/view#general https://sam.gov/opp/31973befa4de49a8a41f5db99f516d40/view#general https://www.hrsa.gov/foia/electronic-reading

• Background

– OPTN Modernization

– Modernization Approach

– OPTN Board

• OPTN Board Support

- Requirements

- Timelines

• Questions & Answers

OVERVIEW

Modernizing the Organ Procurement and

Transplantation Network

Suma Nair, Associate Administrator, Health Systems Bureau

The Organ Procurement and Transplantation Network (OPTN) is a unique public-private partnership that links medical professionals, patients, and other stakeholders involved in the U.S. organ donation and transplantation system.

• Established by National Organ Transplant Act

• OPTN members, as required by law, include all U.S. transplant centers and Organ Procurement

Organizations. OPTN members also include histocompatibility laboratories, public organizations, medical and scientific organizations, businesses, and individuals.

• OPTN responsibilities include:

▪ operate and monitor an equitable system for allocating organs;

▪ work to increase the supply of donated organs;

▪ establish OPTN membership criteria;

▪ monitor compliance with federal laws and OPTN policies;

▪ and manage OPTN data.

WHAT IS THE OPTN?

Health Resources and

Services Administration

Centers for Medicare &

Medicaid Services

Federal Agencies

Organ

Procurement &

Transplantation

Network

Board of Directors

26 Board Support

Committees

Organ Procurement Organizations

Transplant Centers

Histocompatibility Laboratories

OPTN: A UNIQUE PUBLIC/PRIVATE PARTNERSHIP

Seek opportunities to collaborate, communicate, and partner

Build patient clarity & engagement around the transplantation journey

Improve IT infrastructure

Improve organ transport and non-use

Address variation in transplant access & outcomes

Enhance system performance, transparency

& accountability

Improve equity

Strengthen public trust

Patients &

Families

OPTN OPPORTUNITIES

TECHNOLOGY

DATA ANALYTICS

GOVERNANCE

OPERATIONS

INNOVATION

Patients &

Families

The OPTN Modernization

Initiative is centered on putting patients first, prioritizing information flow to clinicians, promoting innovation, and enhancing transparency and accountability.

OPTN MODERNIZATION INITIATIVE

MODERNIZATION APPROACH

1. Single Contract required expertise across all domains

2. Required to be a Private Non-Profit entity with expertise in organ procurement and transplantation

3. Structured to maintain the status quo

1. Multiple, tailored contracts to harness domain-specific, best-in-class expertise

2. Expands pool of expertise across industry by opening eligibility to For-Profit and Non-Profit

3. Design focuses on accountability, transparency, continuous improvement, and innovation

Previous Approach Modernized Approach

PROGRAM

MANAGEMENT

NEXT GENTRANSITION

SECURING THE U.S. ORGAN PROCUREMENT AND

TRANSPLANTATION NETWORK ACT

• Signed into law on September 22,

• Removes the appropriations cap in National Organ Transplant Act of

• Expands the pool of eligible entities and award mechanisms to support the OPTN

• Requires a separate organization to support the OPTN board from the organizations that support OPTN operations

PROGRAM

MANAGEMENT

NEXT GENTRANSITION

BOARD

SUPPORT

OPERATIONS

TRANSITION CONTRACTS

Domain 1 Operations

Domain 2 Matching System

Domain 3 Communications

Domain 4 Research & Evaluation

OPTN Board

Support

Multiple Vendor

Transition Contracts

(For-Profit & Non-Profit)

Single Vendor Contract

(Non-Profit)

BOARD

SUPPORT

OPERATIONS

OPTN GOVERNING BOARD ROLES &

RESPONSIBILITIES

• Develops, reviews, approves, and enforces policies for organ allocation, procurement, and transplantation;

• Establishes committees as necessary to perform the duties of the OPTN;

• Oversees OPTN system operational functions and OPTN committee nominations;

• Supports, establishes, and enforces OPTN membership criteria and transplant and OPO program requirements;

and

• Conducts reviews and evaluations of OPTN members and takes actions as approved by the HHS Secretary or designee that are consistent with the OPTN Final Rule and OPTN Bylaws for OPTN member non-compliance

The Board of Directors is a group of 41 elected members, consisting of:

• 11 OPTN regional councilors

• transplant surgeons, physicians

• histocompatibility experts

• transplant coordinators

• organ procurement organizations (OPOs)

• voluntary health organizations

• medical/scientific membership organizations

• members of the general public, including:

▪ transplant candidates and recipients

▪ living donors

▪ donor family members

▪ recipient & patient family members

Who is on the OPTN Board?WHO IS CURRENTLY ON THE OPTN BOARD?

There are currently 11 OPTN regions

FOCUS GROUPS

OPTN BOARD

RESEARCH

SUBJECT MATTER EXPERTS

INDUSTRY DAY

CRITICAL

INPUTS

DEVELOPING REQUIREMENTS FOR OPTN BOARD

SUPPORT

DEVELOPING REQUIREMENTS FOR OPTN BOARD

SUPPORT

Deconstructed Board

Operations

Deconstructed the Board

Governance operations down to the NOTA level and rebuilt comprehensive list based on functions, authorities, and legislation

Identified Core vs.

Support Functions

Identified functions and activities which can be performed in support of the

Board to minimize conflicts between OPTN Board and operational support contractors

Developed Draft PWS1

Developed draft PWS1 content to reflect the support functions which enable the core OPTN

Board activities, stakeholder feedback and market research

Essential Expertise

Vendors would ideally be mission-driven non-profits with experience in supporting accountable, transparent governance.

1 Performance Work Statement

OPTN Board Support Contract

Manjot Singh, OPTN Modernization Lead, Health Systems Bureau

• Support the Board with its policy development and decision-making of the OPTN committees – which drive who, when, where, and how

Americans receive and give the gift of organs

• Assist the Board in its structure and mechanism to provide equitable access to high quality, timely organ transplantation to everyone in need

• Facilitate the Board’s ability to rapidly and effectively communicate, research, and achieve consensus on policy and enforcement decisions that impact the lives and legacy of organ recipients and donors

PURPOSE

Who is on the OPTN Board?KEY BOARD SUPPORT REQUIREMENTS

High

Performing, Independent

OPTN Board

Administrative Services

BOD Member and Executive Director

Management

BOD Governance

OPTN Governance and Functional

Oversight

General Requirements

Administrative, logistics, and other professional services to support Board of Directors (BOD) operations

Services necessary for the BOD to manage BOD member and Executive

Director positions

Services necessary for the BOD to effectively perform and govern itself

Services necessary for the BOD to perform its OPTN-wide governance and oversight functions

Services to support coordination and collaboration amongst OPTN, HRSA, HHS and other HRSA Contractors.

▪ Facilitate meeting and event logistics

▪ Prepare agendas and presentation materials

▪ Facilitate discussions and presentations

▪ Provide document and content management platforms and repositories

▪ Manage email and correspondence

▪ Facilitate and coordinate internal and external communications

▪ Draft information for dissemination

▪ Compile information to support BOD decision making

TASK AREA 1 – ADMINISTRATIVE SERVICES

▪ Provide the services necessary for BOD oversight of BOD member recruitment

▪ Provide education, training, and other services to ensure BOD members can fulfill their responsibilities

▪ Obtain, provide, and manage indemnification insurance for the BOD members

▪ Develop, implement, and continually revise a plan to monitor and address potential or actual conflicts of interest

▪ Maintain rosters of members of the BOD, their professional affiliations, contact information, and indication of their BOD compositional category

▪ Develop and implement processes for the recruitment, selection, performance evaluation, and dismissal of the OPTN Executive Director

▪ Establish and manage the process to hire and compensate OPTN Executive Director

TASK AREA 2 – BOARD MANAGEMENT

▪ Coordinate and collaborate between the BOD and other actors (e.g. HRSA, operations contractors, etc.)

▪ Ensure effective program and project management

▪ Support BOD access to specialized information and subject matter experts

▪ Support BOD processes and policies management

▪ Ensure continuity of BOD operations, performance metrics and monitoring, and risk management

TASK AREA 3 – BOARD GOVERNANCE

▪ Monitor and facilitate update of the OPTN charter and bylaws

▪ Support the Board in developing, implementing and evaluating OPTN policies

▪ Facilitate internal and external reviews

▪ Provide independent evaluation and financial analysis

▪ Provide access to technical expertise needed to review, approve, implement, and monitor strategic plans and other policies

TASK AREA 4 – OPTN GOVERNANCE AND

FUNCTIONAL OVERSIGHT

ACQUISITION PROCESS

IDENTIFY PLAN RFP AWARD PERFORM

Identify Need Market Research Issue Solicitation Award Contract

Contract

Administration &

Performance

Monitoring

PHASES OF PROCUREMENT

Board Support Contract Indefinite Delivery, Indefinite Quantity Contract

Operations Support Contracts Indefinite Delivery, Indefinite Quantity Contract

Transition Contracts

Domains

• Operations (Selected Vendors)

• Communications (Selected Vendors)

• Matching System (Selected Vendors)

• Research & Evaluation (Selected Vendors)

Tasks

• Administrative Services

• BOD Member and Executive Director

Management

• BOD Governance

• OPTN Governance and Functional Oversight

• General Requirements

OPTN TRANSITION CONTRACTS

OPERATIONS SUPPORT CONTRACT

ANTICIPATED VENDOR REQUIREMENTS

Award Limitations

Eligibility

Eligible to bid on government contracts; offerors will need to register with the System of Award

Management (SAM)

Unrestricted

Full and open to all eligible entities

Experience

Facilitating excellence and innovation through best-in-class expertise in each domain.

Vendor selected for the

Operations Support Contract will not be able to perform the functions of the OPTN Board

Support contract

BOARD SUPPORT CONTRACT

ANTICIPATED VENDOR REQUIREMENTS

Award Limitations

Vendor selected for the Board

Support Contract will not be able to perform the functions of any other OPTN contracts

Eligibility

Eligible to bid on government contracts; offerors will need to register with the System of Award

Management (SAM)

Non-Profit

Board Support

IDIQ is limited to

Non-Profits

Experience

Experience in supporting accountable, transparent governance.

ESTIMATED BOARD SUPPORT IDIQ TIMELINE

Award

Contract

Industry Day

November

December

Publish

Solicitation

Proposals

Received

Winter

Proposal

Evaluation Negotiations

Spring

Q&A

• Suma Nair, Associate Administrator, Health Systems Bureau

• Alexandra “Bonnie” Garcia, HRSA Head of Contracting Activity

• Manjot Singh, OPTN Modernization Lead, Health Systems Bureau

Via Web

Provide feedback on the OPTN

Modernization Initiative at https://www.hrsa.gov/optn-modernization

CONTACT US

https://www.hrsa.gov/optn-modernization

Connect with HRSA

Learn more about our agency at:

www.HRSA.gov

Sign up for the HRSA eNews

FOLLOW US:

http://www.hrsa.gov/ https://public.govdelivery.com/accounts/USHHSHRSA/subscriber/new?qsp=HRSA-subscribe https://public.govdelivery.com/accounts/USHHSHRSA/subscriber/new?qsp=HRSA-subscribe https://facebook.com/HRSAgov/ https://twitter.com/hrsagov https://www.instagram.com/hrsagov/ https://www.linkedin.com/company/us-government-department-of-health-&-human-services-hrsa/ https://www.youtube.com/user/HRSAtube