2018_OPTN_PWS_-_2017.12.01.docx

Performance Work Statement (PWS) Organ Procurement and Transplantation Network (OPTN) Attachment A – OPTN PWS

Performance Work Statement (PWS) Organ Procurement and Transplantation Network (OPTN) Vision Statement

To support the operations and continual improvement of the Organ Procurement and Transplantation Network (OPTN) 1 Introduction The Division of Transplantation (Program), Healthcare Systems Bureau, Health Resources and Services Administration (HRSA) is seeking a contractor to operate the Organ Procurement and Transplantation Network (OPTN)

1.1 Mission

The Program supports HRSA's mission to improve access to quality healthcare and services by increasing the number of deceased donor organs transplanted. The primary purpose of the Program is to extend and enhance the lives of individuals with end-stage organ failure for whom an organ transplant is the most appropriate therapeutic treatment. The Program works towards achieving this goal by providing for a national system, the OPTN, to allocate and distribute donor organs to individuals waiting for an organ transplant. The allocation of organs is guided by organ allocation policies developed by the OPTN with analytic support provided by the Scientific Registry of Transplant Recipients (SRTR).

1.2 Background

The National Organ Transplant Act (NOTA) of 1984 (Public Law 98-507) established the OPTN. Pursuant to NOTA, the OPTN is overseen by contract with HHS and is operated by a private, nonprofit entity with expertise in organ procurement and transplantation. Among its statutory responsibilities, the OPTN must operate and monitor an equitable system for allocating organs, maintain a waiting list of potential recipients, match potential recipients with donor organs, and work to increase the supply of donated organs. The OPTN establishes and maintains membership criteria for institutions, individuals, and interested parties and establishes and maintains training and experience criteria for designated transplant personnel at certain transplant programs. Through committees and the Board of Directors (BOD), the OPTN also establishes, maintains, and monitors compliance with policies and procedures for the allocation of donor organs equitably among transplant patients, in accordance with Federal legislation and regulations. The OPTN must also collect, analyze, and routinely publish data in order to advance the fields of organ transplantation, organ procurement, organ preservation, and immunogenetics.

The addition in 1986 of a new section 1138 to the Social Security Act transformed the OPTN from a voluntary system to one of mandatory participation. Under the revised system, Medicare and Medicaid payments to hospitals and organ procurement organizations (OPOs) depend on membership in the OPTN, and compliance with the “rules and requirements” of the OPTN. HHS issued a Federal Register notice in 1989 indicating that all OPTN policies and standards would remain voluntary until approved by the HHS Secretary and that no OPTN policy was considered a “rule or requirement” of the OPTN unless and until it was approved by the Secretary (54 Fed. Reg. 51802).

On September 8, 1994, HHS published a notice of proposed rulemaking setting forth proposed regulations to govern the operation of the OPTN. On April 2, 1998, HHS issued a final rule governing the operation of the OPTN. OPTN Final Rule, 42 CFR part 121. The OPTN final rule went into effect on March 16, 2000, after a delay in implementation was enacted by the Ticket to Work and Work Incentives Improvement Act (Public Law 106-170).

The Children’s Health Act of 2000 (Public Law 106-310) recognized the differences in health and organ transplantation issues between children and adults and prompted the OPTN to adopt criteria, policies, and procedures that address the unique health care needs of children. In part, the Children’s Health Act of 2000 requires studies and demonstration projects for the purpose of improving procedures for organ procurement and allocation in populations with special needs, including children.

In April 2004 Congress passed the Organ Donation and Recovery Improvement Act (Public Law 108-216), which requires the Secretary to coordinate with the OPTN and other appropriate organizations to support the development and dissemination of educational materials to inform health care professionals on organ donation issues. In 2007, Congress passed the Charlie W. Norwood Living Organ Donation Act (Public Law 110-144). The Act clarifies the legal basis for paired transplants of compatible living donors and recipients, and requires that the Department of Health and Human Services (HHS) report annually on the progress towards understanding the long-term health impacts of living donation.

On December 16, 2011, HHS published a notice of proposed rulemaking in the Federal Register to include Vascularized Composite Allografts (VCAs) within the definition of organs. A final rule was published in July 2013, with an implementation date of July 2014. The purpose of the rule was to facilitate better matching of VCA organs from deceased donors with potential recipients, establish a national registry for patients waiting for a VCA transplant, promote equitable access to available organs, establish minimum requirements for recipient safety and VCA transplant center participation in the OPTN, provide consistency nationwide to procurement, and begin reliable data collection for tracking VCA transplant center outcomes for patient and organ survival (formerly unavailable in the U.S.).

The HIV Organ Policy Equity Act (HOPE Act), signed into law on November 21, 2013, amended the National Organ Transplant Act (NOTA) to remove the prohibition of transplantation of organs procured from HIV-positive donors, and permits transplantation of organs from HIV-positive donors only into recipients who were previously infected with HIV. Initially, these transplants may occur only in the context of clinical research. HRSA worked with CDC and NIH to develop research criteria, published in November 2015. HRSA is in the process of working with the OPTN to review the results of the research, and will present a report to the Secretary by November 2017.

1.3 Scope

In performance of this contract, the Contractor shall meet all of the requirements of NOTA, as amended; other relevant legislation and regulations, including the OPTN final rule; shall support the OPTN in administering the OPTN Charter, Bylaws, and policies (consistent with applicable laws and regulations); and shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities as needed to support the OPTN as indicated in the tasks listed in the PWS. The Bylaws, policies, and structures of any other organization shall not be submitted in the technical proposal or used to guide the operations of the OPTN.

1.4 Purpose

The purpose of this contract is to support the operations and continual improvement of the OPTN.

The major objectives to be accomplished for this performance period include:

(1) Support efforts of the OPTN and the Program to be consistent with the National Organ Transplant Act as amended and the OPTN final rule;

(2) Support the continued improvement of national organ allocation policies to maximize the benefit of transplantation to those with end-stage organ failure;

(3) Continuous evaluation and performance improvement of the OPTN to minimize organ wastage and to maximize transplant benefit, patient safety, and system efficiencies;

(4) Support and increase transparency and efficiency of the OPTN policy development process;

(5) Support the OPTN in the development and implementation of strategic and operational planning systems;

(6) Support the ongoing operation and improvement of the official OPTN Data System to provide timely, complete, efficient, and accurate information for policy development, research, and organ placement purposes;

(7) Provide and implement a system for evaluating member compliance with federal regulations, OPTN Bylaws, and policies;

(8) Conduct research independently and collaborate on research and other analyses with the SRTR and the transplant community to support increased understanding of organ transplant and donation issues that will improve performance of the national transplant system; and

(9) Disseminate information for use by patients and their families, physicians, payers, researchers, and other interested stakeholders.

The functions of the OPTN that the Contractor will support are the following:

1. Maintaining a national list of individuals in need of one or more organ(s) for transplantation.

1. Matching organs to individuals on the waiting list.

1. Establishing and enforcing OPTN membership criteria for member entities.

1. Imposing sanctions on members for violations of membership requirements, consistent with the OPTN Bylaws and OPTN regulations, or recommending to the Secretary that federal sanctions be imposed.

1. Creating policies for the allocation of donated organs consistent with the OPTN final rule.

1. Maintaining a twenty-four-hour system to facilitate organ-recipient matching.

1. Assisting organ procurement organizations (OPO) in the nationwide distribution of organs.

1. Collecting, analyzing, and publishing organ donation and transplantation data.

1. Working actively to increase the supply and utilization of donated organs.

1.5 Period of Performance

The period of performance for the OPTN contract is one (1) 12-month base period and four (4) 12-month option periods (September 30, 2018 – September 29, 2023).

2 General Requirements

2.1 Contract Administration and Management

The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement.

The contractor shall establish processes and assign appropriate resources to effectively administer the requirement. The contractor shall respond to Government requests for contractual actions in a timely fashion. The contractor shall have a single point of contact between the Government and Contractor personnel assigned to support the contract. The contractor shall assign work effort and maintain proper and accurate time keeping records of personnel assigned to work on the requirement.

2.2 Subcontract Management

The Contractor shall be responsible for any subcontract management necessary to integrate work performed on this requirement and shall be responsible and accountable for subcontractor performance on this requirement. The prime contractor shall manage work distribution to ensure there is no Organizational Conflict of Interest (OCI). Contractors may add subcontractors to their team after notification to the Contract Specialist (CS), Contracting Officer (CO), and Contracting Officer Representative (COR).

2.3 Contractor Personnel, Disciplines, and Specialties

The contractor shall accomplish the assigned work by employing and utilizing qualified personnel with appropriate combinations of education, training, and experience. The contractor shall match personnel skills to the work or task with a minimum of under/over employment of resources.

3 Performance Requirements The performance requirements include, but are not limited to, the tasks listed below.

3.1 Contract Administration Requirements

3.1.1 The Contractor shall participate in contract meetings with the COR to discuss current issues relating to the contract.

The Contractor shall hold weekly calls to report on activities and current issues related to the contract. The Contractor shall develop and submit a meeting agenda, in a format approved by the COR, to the COR at least one day before the call. The Contractor shall also prepare summaries of each weekly call and send them electronically to the COR within one business day of the meeting.

In addition, the Contractor shall participate in two in-person meetings per fiscal year (FY) with the COR at HRSA (5600 Fishers Lane, Rockville, MD) to review and report on contract activities and discuss progress and challenges toward achieving the goals of the OPTN, as outlined in the OPTN Strategic Plan (task 3.2.7), and meeting the requirements of the National Organ Transplant Act as amended, the OPTN final rule, and the OPTN contract. The Contractor shall develop a meeting agenda for the bi-annual meetings in consultation with the COR, provide the agenda to the COR two weeks in advance of the meeting, and provide a written meeting summary to the COR within one week following the meeting.

Performance Standards

a) All meeting summaries to include:

1. the key topics and content of discussions,

2. action items with due dates, and

3. supporting information required to follow-up on relevant issues.

b) Meeting summaries require no more than one revision after COR’s comments.

c) Weekly call agenda is sent 1 business day prior to the weekly call.

d) Weekly call summary is sent within one business day following the call.

e) Bi-annual meeting agenda is sent two weeks prior to the meeting for COR feedback.

f) Bi-annual meeting summaries are submitted to COR within one week after the meeting.

Deliverables D01 COR weekly meeting agenda D02 COR weekly meeting summary D03 COR Bi-annual in-person meeting agenda D04 COR Bi-annual in-person meeting summary

3.1.2 The Contractor shall submit quarterly progress reports on contract performance.

The Contractor shall submit written progress reports to the COR within 30 days after the end of each quarter. The Contractor shall, in consultation with the COR, determine the content of these reports, which shall describe the status of Contractor activity in each task.

Performance Standards

a) Quarterly progress reports are submitted within 30 days after end of each quarter of the govern

b) Quarterly progress reports reflect content identified by the COR.

c) Progress reports require no more than one revision after COR’s comments.

Deliverables D05 Quarterly written progress reports

3.1.3 The Contractor shall prepare and submit presentations, abstracts, and manuscripts to major conferences in the fields of organ transplantation, health care delivery and policy, and other relevant disciplines.

The Contractor shall submit 30 days prior to the beginning of each FY quarter for COR approval, a list of proposed presentations at conferences and meetings, and publications (such as peer-reviewed professional journal articles) based on activities conducted under the contract. All abstracts submitted for presentations and conferences, and manuscripts for publication in peer-reviewed scientific journals based on OPTN contract-supported activity shall be submitted to the COR for approval prior to submission. The Contractor shall submit all abstracts and manuscripts based on OPTN analytic or policy-making activity after COR review and approval. The Contractor shall submit a copy of published articles to the COR, and post copies of the articles or links to the articles on the OPTN website.

The Contractor shall also submit annually an application for a symposium at the American Transplant Congress (ATC) to present an annual update on OPTN policy issues and policy development.

Performance Standards

a) Quarterly list of proposed presentations and publications based on OPTN contract activity

b) Proposed abstracts, manuscripts, and conference/meeting presentations provided to COR for approval one week prior to initial submission to journals and conference organizers.

c) Contractor submits ATC symposium application on OPTN policy issues annually. The Contractor notifies the COR once the application is submitted, and notifies the COR once informed of the application’s acceptance or rejection.

d) There should be no more than two COR reviews required per submission.

Deliverables D06 Quarterly list of proposed publications and presentations D07 Draft abstracts, manuscripts, and presentations for initial submission D08 Final abstracts, manuscripts, and presentations for publication D09 Final copies of published articles and presentations D10 Post published materials or links on OPTN web site

3.1.4 The Contractor shall conduct an end-of-contract briefing.

The Contractor shall brief the COR in person at HRSA (5600 Fishers Lane, Rockville, Maryland), no later than 30 days prior to the end of option year 3 of the contract, to discuss accomplishments and lessons learned. The Contractor shall provide recommendations on improvements to the OPTN structure and processes to increase efficiency and effectiveness of the OPTN operations.

Performance Standards

a) Briefing materials are submitted 14 days prior to the meeting.

b) Recommendations focus on suggestions for quality improvement in OPTN structure, activities, and processes in order to increase overall efficiency and effectiveness of the subsequent OPTN contract.

Deliverables D11 In-person briefing D12 Briefing materials

3.1.5 The Contractor shall submit an annual support plan for the OPTN Board of Directors (BOD) and committees.

The Contractor shall submit annually a support plan for the OPTN BOD and committees. The Contractor shall assign staff with combined training and experience in transplant-related issues, public health, health care delivery and finance, health policy, operations/systems research, analytics, and statistics, to provide support to the OPTN BOD and committees. The Contractor shall document in the support plan the expected policy and other issues to be addressed by each group in the upcoming year, a list of assigned Contractor support staff, and their respective roles in supporting the BOD and committees within 90 days after the EDOC. The Contractor shall describe to the COR how it ensures that OPTN committees and the OPTN Board consider and justify compliance with the requirements of the final rule as part of the policy development process. Upon approval by the COR, the Contractor shall implement the BOD and committee support plan, including any changes to the plan subsequently requested by the Contractor and approved by the COR. Committee support plan is updated annually according to the periods of BOD and committee service years and submitted to the COR within 30 days of the beginning of BOD and committee service years, and resubmitted when staff or processes change.

Performance Standards

a) Annual committee support plan includes list of committee liaisons with training and experience to address the need of the OPTN committees.

b) Committee support plan is submitted to the COR within 90 days after the EDOC.

c) Committee support plan must be of high quality and content to justify proposed implementation steps.

Deliverables D13 OPTN BOD and committee support plan

3.1.6 The Contractor shall provide transcripts and summaries of OPTN BOD meetings.

The Contractor shall provide transcripts and summaries of the OPTN BOD meetings to the COR within 30 days of the meeting. The Contractor shall post the summaries on the OPTN website within 7 days of the meeting.

Performance Standards

a) Complete transcripts of each OPTN BOD meeting are posted on the OPTN website within 30 days of the meeting.

b) A summary of each OPTN BOD meeting is posted on the OPTN website within 7 days of the meeting.

c) The summaries document all actions taken by the BOD as well as provide short descriptions of other items discussed by the BOD.

Deliverables D14 OPTN BOD meeting transcripts and summaries D15 OPTN BOD meeting summaries posted on OPTN web site

3.1.7 The Contractor shall submit monthly reports of revenue and expenditures associated with the OPTN contract.

The Contractor shall submit to the COR monthly reports of revenue and expenditures associated with the OPTN contract. These reports shall include a statement of revenues and expenses, a cash flow statement, a receivables aging statement, and a statement of transplant candidate registrations. The expense statement shall include an itemized list of each Contractor staff member’s time billed to the OPTN contract. In addition, the Contractor shall submit monthly financial statements for the primary and reserve accounts and for all OPTN investment accounts. These monthly reports shall also include year-todate summaries of the same information.

Performance Standards

a) Monthly revenue and expenditure reports are submitted to the COR within 7 days of the end of each month.

b) Monthly account statements are submitted to the COR within 7 days of receipt.

Deliverables D16 Revenue and expenditures report D17 Account statements

3.1.8 The Contractor shall submit a proposed OPTN registration fee schedule and associated annual budget.

The Contractor shall submit to the COR for approval its proposed registration fee schedule calculated to cover (together with contract funds awarded by the Secretary) the annual cost of operating the OPTN. Registration fees are charged to each OPTN member when transplant candidates are added to the OPTN wait list. The Contractor shall provide a complete copy of the OPTN budget and budget supporting materials that determine the proposed registration fee schedule to the COR for approval.

Performance Standards

a) Include complete OPTN budget and budget supporting materials with proposed fee schedule.

b) Submit proposed fee schedule to COR for review within 14 days of OPTN BOD consideration.

Deliverables D18 Registration fee schedule proposal D19 OPTN BOD approved budget and budget supporting materials to accompany the fee schedule.

3.1.9 The Contractor shall maintain a web-based platform to facilitate electronic submission of all contract deliverables.

The Contractor shall maintain a web-based platform to facilitate electronic submission of all contract deliverables. The Contractor shall provide the COR will access to the platform within 15 days of EDOC.

Performance Standards

a) The web-based platform allows uploading and downloading of deliverables.

b) The web-based platform allows storage, search and retrieval of deliverables.

c) The web-based platform allows tracking and reporting of deliverable submissions and approval process.

d) The contractor keeps an up to date calendar of all OPTN in-person committee meetings and meetings of the BOD in the web-based platform.

e) The platform will be available to the COR 90% of time.

Deliverables D20 Link to a web-based platform for electronic submission of deliverables

3.1.10 The Contractor shall use a document management platform to allow OPTN governance group members to share documents.

The Contractor shall facilitate collaboration and document sharing among members of OPTN governance groups electronically via a collaboration and document management platform. The Contractor shall deliver the platform to the within 30 days of EDOC.

Performance Standards

a) The electronic document management platform allows for sharing of the documents.

b) The electronic document management platform allows for storage, search and retrieval of committee meeting materials.

c) The electronic document management platform will be accessible to committee members 90% of time

Deliverables D21 Link to the electronic document management platform.

3.2 The Contractor shall establish and maintain an OPTN Governance Structure directed by a Board of Directors (BOD) to oversee OPTN policy development and decision-making.

The Contractor shall ensure that activities of all OPTN governance groups focus on achieving OPTN goals as outlined in the OPTN Strategic Plan (Task 3.2.7) as determined and voted on by the OPTN BOD, the NOTA as amended, the OPTN final rule, and the OPTN contract.

3.2.1. The Contractor shall establish and maintain an OPTN BOD and Executive Committee (EC).

The Contractor shall establish and maintain the OPTN BOD, EC, and BOD ad hoc groups. The Contractor shall ensure that OPTN BOD, EC, and BOD ad hoc group activities are focused on issues relating to achieving the goals of the OPTN, as outlined in the OPTN Strategic Plan (task 3.2.7), and meeting the requirements of the National Organ Transplant Act as amended, the OPTN final rule, and the OPTN contract.

The Contractor shall assist the BOD in performing an annual governance composition review to identify BOD composition goals that meet the requirements described in §121.3(a)(1) of the OPTN final rule and to identify disparities in representation to be targeted in the annual nomination process. The Contractor shall include in this review consideration of the nominations processes undertaken for identifying and nominating regional councilors. The Contractor shall produce a report documenting this review for COR review.

The Contractor shall develop an annual recruiting plan targeting the composition goals and disparities in representation identified in the annual governance composition review. The Contractor shall submit the recruiting plan to the COR two weeks prior to the beginning of the annual nominations process.

Following the annual nominations and elections process, the Contractor shall submit to the COR the names of BOD members and their qualifications (resume, CV), along with an analysis of how the membership of the OPTN BOD meets the composition requirements described in §121.3(a)(1) of the OPTN final rule (42 CFR Part 121), and additional composition criteria that are considered in selecting membership. .

The Contractor shall submit to the COR the names of Executive Committee members along with an analysis of how the membership of the OPTN Executive Committee meets the composition requirements described in §121.3(a)(2) of the OPTN final rule.

The Contractor’s non-OPTN activities shall be addressed at a time other than when the OPTN BOD is performing the duties of the OPTN.

Performance Standards

a) OPTN BOD activities are focused on issues relating to achieving the goals of the OPTN, as outlined in the OPTN Strategic Plan (task 3.2.7), and meeting the requirements of the National Organ Transplant Act as amended, the OPTN final rule, and the OPTN contract

b) The annual review of composition includes review of regional nominations processes and makes recommendations for OPTN regional representation that contributes to meeting BOD composition requirements.

c) The annual recruiting plan guides the annual nominations process and results in elected membership of the BOD meeting the composition goals identified in the annual governance composition review.

Deliverables:

D22 List of names of BOD and EC members D23 Resume/CV of each BOD member D24 Annual governance composition report D25 Annual recruiting plan

3.2.2 The Contractor shall support the OPTN BOD in maintaining the OPTN Charter.

The Contractor shall assist the OPTN BOD in maintaining and modifying as necessary the OPTN Charter describing the structure and operation of the OPTN. The Contractor shall ensure that the OPTN Charter is specific to the OPTN and separate and distinct from any charter that is pertinent to the Contractor’s non-OPTN activities.

The Contractor shall ensure that the OPTN Charter encompasses all aspects of OPTN operations.

The Contractor shall submit proposed updates to the OPTN Charter to the COR for review prior to them being provided to the OPTN BOD for approval.

No later than one year from EDOC, the Contractor shall submit to the COR a plan identifying proposed changes to OPTN membership categories, including the addition of new entities resulting from scientific advances in organ procurement and transplantation.

Performance Standards

a) The Charter is specific only to the OPTN structure and operations.

b) Proposed updates to the Charter are provided to the COR within 14 days of the updates being provided to the BOD for approval.

c) The Charter encompasses all aspects of OPTN structure and operations.

Deliverables:

D26 OPTN Charter

3.2.3 The Contractor shall support an Executive Director of the OPTN identified by the OPTN BOD.

In accordance with §121.3(a)(3) of the OPTN final rule, the OPTN BOD shall appoint an Executive Director of the OPTN. The Executive Director may be reappointed upon the DOB’s determination that the responsibilities of this position have been accomplished successfully. The Contractor shall provide the name of the OPTN Executive Director to the COR when the Executive Director is appointed. The Contractor shall provide the annual evaluation of the Executive Director’s performance to the COR for review prior to the BOD’s decision regarding re-appointment.

Performance Standards:

a) Annual performance review of the OPTN Executive Director is based on objective and measurable criteria that support the goals of the OPTN, as outlined in the OPTN Strategic Plan (task 3.2.7), the National Organ Transplant Act as amended, the OPTN final rule, and the OPTN contract.

Deliverables:

D27 Name of the OPTN Executive Director D28 Annual evaluation of the OPTN Executive Director’s performance

3.2.4. The Contractor shall assist the OPTN BOD in developing, revising, and maintaining OPTN Bylaws, policies, standards, and guidelines for the operation of the OPTN.

The Contractor shall develop, revise, and maintain OPTN Bylaws, policies, standards, and guidelines for the operation of the OPTN. In accordance with federal law and in coordination with the COR, the BOD shall be responsible for developing, with the advice of the OPTN membership and other interested parties, Bylaws and policies that are consistent with the responsibilities of the OPTN, as set forth in Section 372 of the Public Health Service Act (42 U.S.C. § 274) and 42 CFR part 121.

The Contractor shall submit proposed changes to the OPTN Bylaws, policies, standards, and guidelines to the COR for review and prior to review and approval by the BOD. Proposed changes should include proposed changes to OPTN membership categories, including the addition of entities that may result from scientific advances in organ procurement and transplantation.

Performance Standards

a) OPTN policies, Bylaws, standards and guidelines govern the operations of the OPTN, and must conform to NOTA, the final rule, and the Contract. No other policies or Bylaws shall govern the operations of the OPTN.

b) Proposed changes are reviewed by the COR prior to BOD approval.

Deliverables:

D29 OPTN Bylaws, polices, standards and guidelines

3.2.5 The Contractor shall support the OPTN BOD in establishing operating committees.

The Contractor shall support the BOD in establishing and managing standing operating committees identified in tasks 3.2.5.1 through 3.2.5.6 that oversee critical activities and functions necessary for the effective operation of the OPTN. The Contractor shall provide rosters of all committee members to the COR 14 weeks prior to the beginning of new committee terms. The Contractor shall ensure that non-OPTN activities are addressed at a time other than when the OPTN operating committees are performing OPTN duties.

Performance Standards

a) All OPTN operating committees meet in person at least two times per FY.

Deliverables D30 Operating committee rosters

3.2.5.1. The Contractor shall support a Nominating Committee to implement the annual recruiting plan for the OPTN BOD.

The Contractor shall maintain a Nominating Committee to develop and manage an annual OPTN BOD nominations process that is open and transparent and solicits nominations publicly from the donation and transplantation community and broader public. The Contractor shall support the Nominating Committee in identifying nominees for various positions on the OPTN BOD as identified on the recruiting plan (Task 3.2.1, D28).

The Contractor shall support the Nominating Committee by collecting and verifying information about potential nominees. The Nominating Committee shall recommend a final slate of nominees for BOD approval. The Contractor shall submit the list of nominees to the COR within two weeks of conclusion of the nomination process.

Performance Standards:

a) The information collected about each nominee is relevant for the position being considered.

b) The slate of nominees developed by the Nominating Committee includes more than one individual for each open position to be filled, except for those BOD positions filled by reason of the holder’s office.

Deliverables:

D31 Nominations Process D32 Annual list of nominees

3.2.5.2 The Contractor shall establish a Data Advisory Committee.

The Contractor shall establish a Data Advisory Committee (DAC) to review and make recommendations to the BOD regarding the collection of official OPTN data that are pertinent to the operation of the OPTN, necessary for the development of evidence-based OPTN policies, and to support analytic work undertaken by the OPTN Contractor or the SRTR contractor.

The Contractor shall support the DAC in developing a report each FY including recommendations for BOD action on additions and deletions of the data elements collected by the OPTN, recommendations to improve completeness and accuracy of data collected, and any other recommendations to improve collection of official OPTN data, as defined in Task 3.5. The Contractor shall submit the report to the COR within 180 days of EDOC, and within 180 days of the each subsequent contract period. The Contractor shall support the DAC committee chair in making annual presentations of the findings of the review to the BOD and EC.

Performance Standards:

a) The data element review process improves the quality of official OPTN data by improving definitions of data elements.

b) The data review process improves the quality of official OPTN data by monitoring completeness and accuracy of data collected.

c) The data review process improves the quality of official OPTN data by adding data elements supported by outcomes-based evidence to predict outcomes.

d) The data review process reduces the burden of data collection for OPTN members by removing data elements that are incomplete, outdated, or unnecessary.

Deliverables:

D33 Data review report D34 DAC chair report to the BOD and EC

3.2.5.3 The Contractor shall establish a Finance Committee to assist the OPTN BOD in the oversight and financial management of the OPTN.

The Contractor shall support the Finance Committee in developing 1) an annual budget for the OPTN; 2) a multi-year proposed planning budget for the OPTN; 3) annual recommendations to the BOD regarding the OPTN registration fee schedule; and 4) annual recommendations to the OPTN BOD regarding OPTN financial reserves and investment strategy. The Contractor shall submit the proposed annual budget, multi-year budget, and reserves/investment strategy recommendations to the COR within 180 days of EDOC, and within 180 days of the each subsequent contract period. The Contractor shall support the Finance Committee chair in making annual presentations of the annual budget, multi-year budget, and reserves and investment strategy to the BOD and EC.

Performance Standards:

a) Membership includes members with financial expertise from fields other than transplantation.

b) Detailed information is provided to support Finance Committee development of the OPTN FY budget and financial recommendations.

Deliverables:

D35 Annual OPTN FY Budget D36 Annual multi-year planning budget D37 Annual recommendations regarding OPTN reserves and investment strategy

3.2.5.4. The Contractor shall establish a Policy Oversight Committee (POC) to assist the OPTN BOD in prioritizing OPTN policy development activities.

The BOD shall establish a POC to advise and support the OPTN BOD and EC in:

· strategic planning activities;

· prioritization of OPTN policy development activities based upon the OPTN strategic plan (task 3.2.7), potential financial impact of the activity, and requirements that proposed OPTN activities are consistent with NOTA, the OPTN final rule, and any specific direction that may be provided by the HHS Secretary;

· evaluating policy proposals prior to public comment;

· coordinating policy issues that have broad implications across OPTN committees;

· ensuring that the OPTN committees and the OPTN BOD consider and justify compliance with the requirements of the final rule as part of the policy development process.

The Contractor shall provide meeting materials to support POC decision-making on prioritization of OPTN policy development activities. The meeting materials developed by the Contractor shall include information on the OPTN resources necessary to undertake the effort and information regarding the financial impact on stakeholders. The Contractor shall support the committee chair in making presentations to the BOD and EC.

Performance Standards:

a) The meeting materials support the POC in their decision-making role.

b) The meeting materials are responsive to POC’s requests for information.

c) The meeting materials provided support POC in evaluating and recommending the committee proposals to move forward to public comment.

Deliverables:

D38 POC recommendations to the EC and/or BOD D39 POC chair presentation to the EC and/or BOD

3.2.5.5. The Contractor shall establish a Network Operations Oversight Committee The OPTN BOD shall establish a Network Operations Oversight Committee to assist the OPTN BOD in the oversight of the OPTN operations, including but not limited to the OPTN matching function, the collection of all official OPTN data (as defined in task 3.5), including data from donors, candidates and recipients required for the OPTN matching function, and the automated organ packaging, labeling and tracking process, TransNet.

The Contractor shall support the committee in developing metrics to:

· monitor the efficiency and effectiveness of the OPTN matching function, including conformance of matching function to OPTN BOD approved policies;

· monitor timeframes for implementing BOD approved policies, based on complexity of work

· monitor the frequency of revisions post-implementation; and

· monitor progress toward seamless data linkages with electronic medical record systems of OPTN members to reduce data collection burden.

The Contractor shall assist the committee in developing an annual review of network operations metrics and submit the report to the COR within 180 days of EDOC, and 180 days from the beginning of subsequent contract periods. The Contractor shall support the committee chair in making annual presentations of the findings of the metrics review to the BOD and EC.

Performance standards:

a) Committee review and report of metrics includes the following:

· Assessment of match run outcomes reflecting OPTN BOD approved policies.

· Timing of policy/programming implementation following approval by the BOD

· Status of improved data linkage to members and resulting improvement in data quality (as identified in the DAC data process report) and reduction in data entry burden on members.

Deliverables:

D40 Network Operations Metrics and Monitoring Report D41 Committee chair presentation to the EC and/or BOD

3.2.5.6. The Contractor shall maintain a Membership and Professional Standards Committee (MPSC) to monitor and improve OPTN member performance and to recommend and impose sanctions on OPTN members for violations, consistent with the OPTN Bylaws and final rule.

The BOD shall establish an MPSC to maintain membership criteria and monitor OPTN members for compliance with OPTN membership criteria; OPTN Bylaws, policies, and the OPTN final rule. The Contractor shall support the MPSC to review the performance of OPTN members as described in task 3.6, and address events identified as presenting a risk to patient safety and public health. The Contractor shall include the COR and COR-designated HRSA staff in all MPSC deliberations.

The Contractor shall support no less than 3 MPSC in-person meetings and 2 conference calls per FY. The Contractor shall provide a secure online meeting platform to support MPSC in evaluating member performance and compliance with OPTN Bylaws, policies and the OPTN final rule.

Performance Standards:

a) OPTN members in compliance with OPTN membership criteria, OPTN Bylaws and policies and Bylaws, and the OPTN final rule

b) Risks to the health of patients or the public safety, consistent with the requirements of §121.10 of the OPTN final rule are identified.

c) Transplant program criteria are established, when applicable, under §121.9 of the OPTN final rule

Deliverables:

See 3.2.5

3.2.6 The Contractor shall support the OPTN BOD in establishing and maintaining policy development committees and expert groups to address critical OPTN policy issues.

The Contractor shall support the OPTN BOD in establishing and maintaining policy development committees and other groups of experts to address critical policy issues. The Contractor shall develop an annual OPTN policy plan, for COR review and approval, identifying committees and expert groups representing critical areas of system expertise necessary to address policy issues in the upcoming committee term year.

The Contractor shall identify in the annual OPTN policy plan committees charged to develop policy in areas where broad policy development is expected to be needed in the upcoming year. The Contractor shall ensure that all committees develop policies in accordance with the requirements set forth in the OPTN final rule.

The Contractor shall also identify in the plan, panels of experts possessing areas of knowledge that is necessary to inform all OPTN policy development, as well as a process to ensure input throughout the policy development process from these expert panels.

The Contractor shall submit the OPTN policy plan to the COR for review and approval within 180 days of EDOC and COR approval must be obtained prior to Contractor submitting plan to the BOD for approval. In option periods of the contract, the Contractor shall submit the committee plan to the COR for review and approval within 180 days of the beginning of the option period and COR approval must be obtained prior to Contractor submitting plan to the BOD for approval.

The Contractor shall also submit a list of members identified for each committee and expert group, role of each member, and reasons for any simultaneous service on different committees. The Contractor shall submit the list with resumes and CVs to the COR annually no later than 60 days prior to the beginning of new committee or panel terms. The Contractor shall notify the COR in writing when members and chairs of committee or expert panels change.

Performance Standards:

a) The Contractor shall ensure that policy development committees and expert group membership is consistent with the requirements of the OPTN final rule §121.3(a)(4).

b) Committee plan provides an informed understanding of proposed OPTN policy development.

c) Committee plan ensures input from all relevant areas of expertise at appropriate times in the policy development process.

d) Committee plan provided for COR review and approval prior to submitting plant to BOD.

e) List of committee members and expert panel includes CVs and rationale for each member’s participation.

f) All work of the OPTN committees assists the OPTN BOD in carrying out its duties under the scope of the contract, NOTA, and the final rule.

Deliverables:

D42 Annual OPTN policy plan D43 List of committee members and CVs for each committee and expert group

3.2.6.1 The Contractor shall develop a plan to recruit individuals with relevant expertise for service on OPTN policy development committees and groups.

The Contractor shall develop an open and transparent plan to recruit and nominate individuals for OPTN policy development committees and expert groups, with expertise relevant to the subject matter and work of the committees and groups. The Contractor shall ensure that there is a clear process and criteria for the selection of committee and group leadership (chairs and vice chairs). The Contractor shall submit the plan to the COR for review within 180 days of EDOC. The Contractor shall support implementation of the plan after OPTN BOD approval. The Contractor shall post the policy development recruiting and nominations plan on the OPTN web site.

Performance Standards:

a) Open and transparent process demonstrated by public announcement and OPTN regional outreach efforts to reach the broad transplant community.

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

c) There is an 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.

d) There is a clear process and criteria for the selection of committee and group leadership (chairs and vice chairs).

Deliverables:

D44 OPTN Policy development recruiting and nominations plan

3.2.7 The Contractor shall support the OPTN BOD in developing an OPTN strategic plan.

The Contractor shall support the OPTN BOD in strategic planning activity to provide annual planning and long-term goals to target OPTN resource planning on improvement and innovation in response to advances in medicine and technology and changes in the regulatory, legal, and social environments. The Contractor shall ensure that the goals identified in the OPTN strategic plan address requirements for OPTN performance identified in NOTA as amended, the OPTN final rule, and the OPTN contract. The BOD shall monitor the progress in achieving the goals identified in the strategic plan. The Contractor shall conduct the OPTN strategic planning activity every five-years.

The Contractor shall submit draft OPTN Strategic Plan to the COR for review prior to review and approval by the OPTN BOD. The Contractor shall submit an annual report to the COR on the OPTN’s progress in achieving the goals identified in the OPTN Strategic Plan.

Performance Standards:

a) OPTN strategic plan goals address requirements for OPTN performance identified in NOTA as amended, the OPTN final rule, and the OPTN contract.

b) Progress is reviewed annually.

c) The strategic plan is updated every five years to respond to changing needs of the transplant community and keep pace with the medical and technology advances.

Deliverables:

D45 OPTN strategic plan D46 Annual report on strategic plan progress

3.2.8 The Contractor shall provide administrative and logistical support to the OPTN BOD and committees to perform their functions under this contract.

The Contractor shall provide administrative and logistical support to the OPTN BOD and committees to perform their functions under the OPTN contract. The OPTN Contractor shall support communication and coordination among OPTN committees, subcommittees, and ad hoc groups throughout the policy development process.

3.2.8.1 The Contractor shall develop an education plan to provide ongoing training and education to the OPTN BOD, members of OPTN operating and policy development committees/expert groups, and regional OPTN members.

The Contractor shall develop and implement a plan to provide structured education to members of the BOD, operating committees, policy development committees/groups, and to OPTN regional members about the legislative and regulatory requirements of the OPTN to facilitate informed OPTN policy making.

The Contractor shall submit this plan to the COR for review and approval within 180 days of EDOC, and as updated.

Performance Standards:

a) OPTN BOD members, operating committee members, committee members, and regional members receive structured education on the statutory and regulatory requirements of the OPTN.

Deliverables:

D47 Education plan

3.2.8.2 The Contractor shall develop policies and procedures to prospectively identify and address potential and actual conflicts of interests.

The Contractor shall develop policies and procedures, to be approved by the COR, to prospectively identify and address potential and actual conflicts of interests among individuals participating in OPTN governance and policy development activities. These procedures shall be specified in the OPTN Bylaws. The Contractor shall ensure that such policies and procedures are followed at all times should a conflict, or perceived conflict, arise during BOD, EC, or other committee deliberations or decision-making.

The Contractor shall annually provide conflict of interest policies, procedures, and signed conflict of interest statements for all members of the OPTN BOD, operating committees, and policy development committees to the COR. The Contractor shall submit to the COR two weeks prior to each meeting of the OPTN BOD and MPSC a list identifying potential conflicts of interest that may arise as the result of issues or OPTN members under discussion at the meeting together with proposed mitigating strategies.

Performance Standards:

a) Conflicts of interest are addressed in each BOD or other OPTN committee meeting, as applicable.

b) A list of potential conflicts of interests and mitigating strategies submitted to the COR two weeks prior to each BOD meeting.

Deliverables:

D48 Signed conflict of interest statements D49 List of potential conflicts of interests and mitigating strategies D50 Policies and procedures to identify and address conflicts of interest

3.2.8.3 The Contractor shall provide public access to OPTN governance activities.

The Contractor shall provide general public access to public sessions of OPTN meetings via teleconference, webinar, or other technologies to ensure openness and transparency of OPTN governance. The Contractor shall ensure a designated period for public comment is included in the agenda of all OPTN meetings. The OPTN website calendar shall be updated at least weekly to reflect current meeting schedules and OPTN activities, and provide information to allow interested members of the public to participate in designated public comment periods in OPTN governance activities.

HRSA acknowledges that there is occasional need for closed sessions of the OPTN BOD or committees to address…