ATTACH O - Sample Task Order for Domain 2 Operations.pdf

OPTN Operations IDIQ RFP No. 75R60224R00008 Attachment O: Nonawardable (Sample) Task Order for Domain 2 Operations

Sample Task Order Title: Domain 2 OPTN Operations

Date: April 29, 2024

I. BACKGROUND

The Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), oversees the nation’s Organ Procurement and Transplantation Network (OPTN), as authorized by the National Organ Transplant Act of 1984, as amended (42 U.S.C. § 273 et seq.), and the OPTN regulations (OPTN Final Rule), codified at 42 CFR part 121. The OPTN consists of a comprehensive network of transplant professionals, community members, and others charged with increasing organ donation and operating and overseeing a fair and accountable system for allocating and transplanting organs in the United States. The OPTN Board of Directors provides governance and management of the OPTN and OPTN committees provide recommendations and guidance to the OPTN Board of Directors to inform its decisions. Committees are comprised of OPTN Board of Directors members and subject matter experts who volunteer to support the OPTN. An overview of the OPTN committees is in Attachment A.

II. PURPOSE AND PROBLEM STATEMENT

The purpose of this task order is to encompass the provision of administrative, logistic, legal, research, analytic, and management services related to the operations of the OPTN, including services related to coordinating and facilitating OPTN committee functions, budget and accounting, financial audits and planning, event management, OPTN member education, provision of member technical assistance and quality improvement activities, development and monitoring of OPTN membership criteria, policy compliance and performance monitoring, OPTN volunteer recruitment and nomination processes, and policy development.

III. PERIOD OF PERFORMANCE/PLACE OF PERFORMANCE

The period of performance shall be one base year of twelve (12) months from the effective date of the contract (EDOC). The place of performance shall be off-site at the contractor’s location.

IV. TASKS

1. Coordination and Support Services for OPTN Membership and Professional Standards Committee

On behalf of the OPTN Board of Directors, the OPTN Membership and Professional Standards Committee (MPSC) maintains membership criteria, monitors member compliance, and makes recommendations for member quality improvement.

1.1 OPTN Membership

OPTN member organizations play a critical role in the operations of the OPTN in providing equitable access to lifesaving and life enhancing transplants to individuals who need a transplant. Individuals from member organizations participate in the decision-making process of the OPTN. OPTN organization member categories currently defined in the bylaws include transplant hospitals, Organ

Procurement Organizations (OPOs), histocompatibility laboratories, medical/scientific institutions, public organizations, and businesses. Individuals are also able to be OPTN members.

The Contractor shall:

1. Draft with the MPSC, for OPTN Board of Directors for review and approval, processes for the

OPTN Board of Directors to maintain, and continually review, monitor, and evaluate membership categories, criteria and standards and hold members accountable for complying with membership criteria and standards.

2. Ensure that membership criteria and standards are compliant with NOTA, OPTN Final Rule, OPTN requirements, contract requirements (including member information technology and data security requirements), and other applicable federal laws and regulations.

1.2 OPTN Member Compliance and Performance Monitoring Plan

The Contractor shall:

1. Draft with the MPSC for OPTN Board of Directors input, an Annual OPTN Member Compliance and Performance Monitoring Plan

2. Submit the draft Annual OPTN Member Compliance and Performance Monitoring Plan, electronically to the COR for review and approval within thirty (30) calendar days of the EDOC. The OPTN Member Compliance and Performance Monitoring Plan shall describe:

a) The processes used by the MPSC and the Contractor to monitor compliance with OPTN policies, promote performance improvement, and enforce policy and public safety requirements. If confidential medical peer review processes are proposed, a rationale for these processes shall be included, along with a description as to how the confidentiality of the processes will be protected under applicable law. All processes used to track and move complaints and incidents through the compliance process shall be described;

b) Performance metrics for OPTN members;

c) The review and approval process for OPTN membership applications. At minimum, the process shall include:

1) Monitoring all OPTN members for compliance with the requirements of

NOTA, the OPTN Final Rule, OPTN Bylaws and policies;

2) Approach for educating and encouraging OPTN member compliance with the requirements of NOTA, the OPTN Final Rule, OPTN Bylaws, and OPTN policies;

3) Approach for promoting member performance improvement to meet Final Rule and OPTN requirements;

4) Approach for identifying potential patient safety issues and developing corrective action plans to mitigate risk;

5) Approach for provision of technical assistance to members;

6) Approach for developing and maintaining OPTN Bylaws and policies describing patient safety reporting requirements and the enforcement process that may result in OPTN and/or federal sanctions against OPTN members if the member fails to mitigate patient safety threats;

7) Development and maintenance of a real-time membership status report for the OPTN website documenting the membership status of OPTN members;

8) Approach for educating and encouraging member self-reporting of potential compliance problems and providing support for members to report issues;

OPTN Operations IDIQ

Attachment O: Nonawardable (Sample) Task Order for Domain 2 Operations

9) Processes and timelines for reporting member compliance and performance status to the COR;

10) Processes for imposing OPTN sanctions as determined by the OPTN Board of Directors and referring members to the Secretary of HHS when federal sanctions may be warranted; and

11) Timelines and milestones for completing all the activities under the annual OPTN Member Compliance and Performance Monitoring Plan.

3. Submit a final OPTN Member Compliance and Performance Monitoring plan addressing all COR feedback electronically to the COR for review and approval within three (3) business days after receipt of COR feedback.

4. Assist the MPSC in presenting the COR-approved OPTN Member Compliance and Performance Monitoring Plan to the OPTN Board of Directors, for review and approval.

5. After OPTN Board of Directors approval, assist the MPSC in implementing and managing the OPTN Member Compliance and Performance Monitoring Plan.

6. Provide status updates to the COR during weekly status meetings and Quarterly Progress Reports and meetings detailing work done since the last status update and upcoming work and action items.

1.3 Compliance and Monitoring Process Metrics

The Contractor shall:

1. Draft, with input from the MPSC and OPTN Board of Directors, metrics to assess the effectiveness of compliance and monitoring processes.

2. Submit draft Metrics electronically to the COR for review and approval in accordance with the final Annual OPTN Member Compliance and Performance Monitoring Plan.

3. Submit final Metrics addressing all COR feedback electronically to the COR for review and approval within three (3) business days after receipt of COR feedback.

1.4 Monitoring Activity Report

The Contractor shall:

1. Draft with the MPSC an Annual Baseline Compliance Report using a template proposed by the Contractor electronically to the COR for review and approval within thirty (30) calendar days after the EDOC. The draft Annual Baseline Compliance Report, at a minimum, shall include the following:

a) Monitoring, compliance, enforcement status, and history of enforcement actions of each OPTN member, including member inactivity and continued compliance with OPTN membership criteria and standards;

b) Summary of the completeness of data submitted by each OPTN member; and

c) Analysis of trends in member performance and compliance and member participation in Contractor activities to improve performance and compliance.

2. Submit a final Annual Baseline Compliance Report addressing all COR feedback electronically to the COR for review and approval within ten (10) calendar days after receipt of COR feedback.

3. Provide updates to the MPSC and aggregated results regarding data submission to the DAC, on a schedule determined with the COR and approved by the COR.

1.5 Review and Periodic Reassessment of OPTN Membership Applications

The Contractor shall:

OPTN Operations IDIQ

1. Submit a draft OPTN Membership Application Report with a written description of the process contained in the OPTN Bylaws for OPTN membership application review and approval in accordance with the final Annual OPTN Member Compliance and Performance Monitoring Plan electronically to the COR.

2. Submit a Monthly Membership Status Report to the COR within five (5) business days after the end of each month. The Monthly Membership Status Report shall include at a minimum:

a) Membership status of all OPTN members;

b) Approved key staff for each institutional OPTN member; and

c) Ensure that information about approved key staff for each institutional OPTN member is up to date.

1.6 Collaborative OPTN Member Performance Improvement Models

The Contractor shall:

1. Draft with the MPSC for OPTN Board of Directors input, within sixty (60) calendar days after the EDOC, a Collaborative Performance Improvement Plan (CPIP) to increase the OPTN’s efforts at monitoring and improving OPTN member performance.

2. Submit OPTN Board of Directors approved CPIP electronically to the COR for review within five (5) business days after OPTN Board of Directors approval. The CPIP shall include, at minimum:

a) Process used to identify proposed new models and metrics for monitoring and improving member performance;

b) Outline of proposed models for the contract period—models shall cover all phases of the organ donation, procurement, matching, and transplantation process;

description of the staffing plan for each model, including documentation of staff structure capable of supporting in-depth understanding of the model;

c) Staff processes to provide appropriate feedback to OPTN members and to address emerging performance issues in real time;

d) Processes and metrics for identifying process and quality issues in real time, and process for developing targeted interventions to address identified issues;

e) A process to collaborate with the SRTR contractor to develop data reports and tools to provide feedback to members;

f) Proposed tools and vehicles to foster collaborative learning;

g) Utilization of evidence-based and data driven approaches to identify and disseminate best practices; and

h) Collaborative quality improvement opportunities both to members seeking to improve performance based on goals of the OPTN, as well as to members in need of performance improvement;

3. Submit a final CPIP addressing all COR feedback electronically to the COR for approval within ten (10) calendar days after receipt of COR feedback.

4. Assist the MPSC in presenting the COR-approved CPIP to the OPTN Board of Directors, for review and approval.

5. Provide all services necessary for the MPSC to implement the COR approved CPIP.

6. Provide status updates to the COR during the weekly meetings and quarterly reports detailing work done since the last status update and upcoming work and action items.

7. Submit a draft Member Performance Model Annual Report on the proposed models and metrics for monitoring and improving OPTN member performance electronically to the COR for review and approval thirty (30) calendar days before the end of the base year. If the COR

OPTN Operations IDIQ requires any changes, submit a final Member Performance Model Annual Report electronically to the COR within five (5) business days after receipt of COR feedback.

1.7 Review of Waitlist Acceptance Criteria and Processes

The Contractor shall:

1. Provide support services to the MPSC for the development, in coordination with the OPTN Board of Directors, a Waitlist Acceptance Criteria Assessment Plan within sixty (60) calendar days of EDOC. The Waitlist Acceptance Criteria Assessment Plan is to conduct a comprehensive review and assessment of waitlist acceptance criteria and processes of OPTN members. The Waitlist Acceptance Criteria Assessment Plan shall include, at minimum:

a) Timelines and milestones for the collection and assessment of written waitlist acceptance criteria (as required in OPTN policy) from all OPTN member transplant programs and the assessment shall:

1) Document and identify variability in processes;

2) Identify potential issues affecting equity in access to the transplant waitlist;

3) Identify recommendations for OPTN policymaking and quality improvement activity to reduce variability in waitlisting practices and issues affecting equity in waitlist access; and

4) Describe dissemination approach for public awareness transplant center specific differences in waitlist acceptance criteria and processes.

2. Submit the draft Waitlist Acceptance Criteria Assessment Plan, approved by the OPTN Board of Directors, electronically to the COR for review and approval five (5) business days after OPTN Board of Directors approval. If the COR requires changes, submit a final Waitlist Acceptance Criteria Assessment Plan electronically to the COR within five (5) business days after receipt of COR feedback.

3. Provide all services necessary for the OPTN to implement the approved waitlist acceptance criteria assessment plan.

4. Provide status updates to the COR during the Weekly status meetings and quarterly reports and meetings detailing work done since the last status update and upcoming work and action items.

5. Submit a Waitlist Acceptance Report of Findings to the COR in accordance with the final Waitlist Acceptance Criteria Assessment Plan. The report shall include, at a minimum:

a) summary analyses of transplant center written waitlist acceptance criteria and processes, including documentation of variability in process;

b) transplant centers that currently make their waitlist acceptance criteria and processes available to the public;

c) identification of potential issues affecting equity in access to the transplant waitlist;

d) recommendations for OPTN policymaking and quality improvement activity to reduce variability in waitlisting practices and issues affecting equity in waitlist access; and

e) proposed approach to address equity concerns including timelines.

6. Based on the Waitlist Acceptance Report of Findings , provide all services necessary to support the OPTN in:

a) revising its policies regarding standardization of OPTN member waitlist acceptance criteria and processes to ensure compliance with NOTA, OPTN Final Rule, OPTN policies, and OPTN contract requirements. The policies shall include minimum standards that every transplant center shall address in their waitlist acceptance criteria and processes; and

OPTN Operations IDIQ

b) after OPTN Board of Directors approval, monitoring transplant centers’ implementation of revised OPTN policies regarding member waitlist acceptance criteria and processes.

2. Coordination and Support Services for OPTN Network Operations Oversight Committee The Network Operations Oversight Committee (NOOC) assists the OPTN Board of Directors in its role in operations, including the OPTN matching function; and the process of official OPTN data collection, including data from potential donors, deceased donors, living donors, transplant candidates, and transplant recipients required for the OPTN matching function..

The Contractor shall:

1. Provide support services to the NOOC in developing objective metrics to:

a) monitor the efficiency and effectiveness of the OPTN matching function, including matching request count and rate, error count and rate, and match latency (average, 95th and 99th percentile); conformance of matching function to OPTN Board of Directors approved policies;

b) monitor implementation timeline, including any delays, between OPTN Board of Directors policy approvals and their implementation, validation, and production rollout for use by all clients;

c) monitor the frequency of policy programing defect repair revisions occurring post-implementation, and the delay between defect detection and the fix rolling out and becoming accessible to all clients; and

d) monitor progress, measured as total manual- and API-based electronic data submissions, toward ubiquitous direct electronic data submission from electronic medical record systems of OPTN members to reduce data collection burden.

2. Provide support services to the NOOC for development of an annual review of network operations metrics and submit the Network Operations Report to the COR prior to the end of the base year.

3. Provide support services to the NOOC committee chair to make annual presentations of the findings of the metrics review to the OPTN Board of Directors and EC.

4. Provide the services necessary for the NOOC to:

a) define goals and tactics to drive wider API adoption, and establish requirements for member compliance agreements for API usage and integration;

b) develop a plan for the Contractor to inform OPTN members of any security notifications received by the Contractor and expectations for OPTN member response;

c) review existing IT performance metrics for the system and include new metrics on

Contractor performance and OPTN member performance;

d) develop public facing dashboard on system performance metrics including documentation of OPTN member organizations use of APIs;

e) develop an online dashboard showing API unitization and performance for the various functions;

f) establish security requirements as a part of the member compliance agreement(s) for

API usage and integration;

g) establish an OPTN member security framework including security compliance language for OPTN members, as described in more detail below;

h) develop a process to monitor member compliance with the OPTN member security framework established by the NOOC;

OPTN Operations IDIQ

i) develop criteria for suspending both OPTN member organizations and OPTN member user accounts from network;

j) develop criteria for what is needed to re-enable accounts after suspension and communicate this to OPTN members; and

k) develop process and timeline for reporting OPTN member incidents (by category of severity) to HRSA.

5. Provide support services to the NOOC to establish security framework(s) for OPTN members based on the type of OPTN member organization, including development of annual training requirements for both OPTN member site administrators and OPTN member users. All security frameworks shall require OPTN members to:

a) comply with Security language that refers to a selected security framework;

b) participate in routine security audits based on the NOOC-developed OPTN security framework;

c) ensure that all OPTN member site administrators and all OPTN member users complete and pass a COR approved and Contractor administered annual security awareness training and exam;

d) complete annual Contractor security data call for all OPTN members against security framework;

e) self-attest annually that OPTN members are following the security framework;

f) sign all required API member compliance agreements;

g) require notification of OPTN member incidents to the Contractor within one (1) day of occurrence; and

h) meet operational incident response within one (1) day or in accordance with expectations as defined by the NOOC (e.g., reporting on time to detect security incident, time to mitigation, time to restoration; require root cause analysis and post-mortem report generation; etc.).

3. Coordination and Support Services for OPTN Policy Committees

The Policy Oversight Committee (POC) and other OPTN components advise the OPTN Board of Directors on the development, prioritization, coordination, evaluation prior to public comment, impact assessment, and justification of proposed OPTN policies.

3.1 Policy Development Process

The Contractor shall:

1. Provide support services to the POC and OPTN Board of Directors to draft, within sixty (60) calendar days after the EDOC, an OPTN Policy Development Plan and Process to manage OPTN policy development, implementation, monitoring and assessment. The OPTN Policy Development Plan and Process shall include, at a minimum:

a) Approach for policy development committees to provide recommendations and guidance to the OPTN Board of Directors on policy issues.

b) Approach to support OPTN regions for:

1) Providing an effective mechanism for communication among OPTN staff, OPTN Board of Directors, and the transplant community;

2) Facilitating the identification of geographically diverse transplant professionals to populate both the OPTN Board of Directors and OPTN Committees; and

3) Providing a forum for consensus building and transparency of work throughout the OPTN policy development process through regional meetings

OPTN Operations IDIQ

c) Approach for prioritization and approval of projects taking into accounts life-cycle costs, impact on the network, alignment with OPTN goals, statute, regulation, and contract requirements;

d) Approach for soliciting public input on proposed OPTN policies and other actions as appropriate.

2. Submit the OPTN Board of Directors approved OPTN Policy Development Plan and Process electronically to the COR for approval five (5) business days after OPTN Board of Directors approval. If COR requires changes, submit a final OPTN Policy Development Plan and Process electronically to the COR within five (5) business days after receipt of COR feedback.

3. Provide all services necessary for the OPTN to implement the approved OPTN Policy Development Plan and Process.

4. Provide status updates to the COR during the weekly status meetings and quarterly reports and meetings detailing work done since the last status update and upcoming work and action items.

3.2 OPTN Policy Variances

OPTN policy variances currently include alternative allocation systems, alternative local units, sharing arrangements, and alternative point assignment systems.

The Contractor shall:

1. Provide support services to the POC and OPTN Board of Directors to manage, maintain, update, and implement OPTN policy variances in accordance with OPTN policies.

2. Ensure that proposed variances comply with NOTA and the OPTN Final Rule and OPTN policies.

3. Provide support services to the POC to submit a draft OPTN Policy Variances Process detailing the review and approval process for OPTN variances electronically to the COR for review and approval within thirty (30) calendar days of the EDOC. The OPTN Policy Variances Process shall include the approach and tools for reviewing, maintaining, and updating the variance requests.

4. Submit a final OPTN Policy Variances Process addressing all COR feedback electronically to the COR for review and approval within five (5) business after receipt of COR feedback.

5. Assist the POC in presenting the COR-approved CPIP to the OPTN Board of Directors, for review and approval.

6. Coordinate with and provide support services to the relevant OPTN entities in accordance with the approved OPTN Policy Variances Process to coordinate the OPTN Board of Directors review and approval of all proposed variances in accordance with the approved OPTN Policy Variances Process.

7. Monitor all OPTN Board of Directors approved OPTN policy variances to ensure compliance with requirements in the OPTN Final Rule and OPTN policies.

8. Submit an Annual Approved Variances Status Report on all approved variances to the OPTN Board of Directors and COR electronically within sixty (60) days of OPTN Board of Directors review of proposed variances. The Annual Approved Variances Status Report shall indicate whether OPTN members are implementing the variances as approved, the implementation schedule, and expiration dates.

9. Coordinate with the OPTN operations contractor(s) responsible for communications to publish approved OPTN variances on the OPTN website within ten (10) calendar days after OPTN Board of Directors approval.

3.3 OPTN Policy Development Metrics

OPTN Operations IDIQ

The Contractor shall:

1. Provide support services to the POC to draft Policy Procedures and Metrics to assess policy development and implementation electronically to the COR for review and approval within thirty (30) days of the EDOC. The metrics shall:

a) Measure the effectiveness of the OPTN policy development process;

b) Measure compliance of OPTN policies with NOTA, the OPTN Final Rule, the

OPTN contract, and other applicable federal laws and regulations; and

c) Assess the effectiveness of the OPTN policy implementation.

2. Submit a final Policy Procedures and Metrics addressing all COR feedback electronically to the COR for review and approval within five (5) business after receipt of COR feedback.

3. Submit status updates on the metrics and findings in the Quarterly Reports to the COR.

4. Provide the COR approved Policy Procedures and Metrics to the OPTN POC.

5. Develop an Annual Policy Metrics Public Presentation in consultation with the OPTN

POC for the OPTN POC to share the findings at the OPTN Board of Directors meeting.

6. Submit the presentation to the COR for review and approval at least twenty (20) calendar days prior to OPTN Board of Directors’ meeting. If the COR requires any changes, submit a final presentation electronically to the COR within five (5) business days after receipt of COR feedback.

4. Coordination and Support Services for OPTN Data Collection, Oversight, and Administration

The OPTN Data Advisory Committee (DAC) reviews and makes recommendations to the OPTN Board of Directors concerning collecting or improving OPTN data. This includes maintaining the OPTN Data Collection Principles, ensuring data collection activities align with those principles, overseeing data collection recommendations, improving and enhancing data elements collected by the OPTN, recommending data policies, and supporting the analytic work done across OPTN committees or on behalf of the OPTN.

The Contractor shall:

1. Work with the DAC to:

a) establish and maintain data governance and data standards for all OPTN data, in compliance with applicable Federal law;

b) develop processes to document, collect, and secure all data necessary for OPTN operations, in compliance with applicable Federal law; and

c) coordinate DAC work with other OPTN committees to identify and prioritize changes in OPTN data collection and OPTN data standards.

5. Coordination and Support Services for Budget, Financial, and Audit Functions

The Finance Committee serves in an advisory capacity to the OPTN Board of Directors to review financial policies, goals, and budgets that support the Strategic Plan of the OPTN, reviewing the OPTN’s financial performance against short-term and long-term goals.

5.1 Budget, Accounting, and Registration Fees Services

The OPTN fiscal year is October 1 through September 30. Two streams of funding support OPTN activities: federal appropriated funds and registration fees paid by transplant centers for each patient they place on the national organ transplant waiting list. Currently, this is a one-time registration fee for each patient.

OPTN Operations IDIQ

The Contractor shall:

1. With the Finance Committee and the OPTN Board of Directors to draft OPTN Registration

Fee Procedures to bill, collect, manage, and use OPTN registration fees to support OPTN operations, within sixty (60) calendars of EDOC. The draft Procedures must be compliant with the OPTN Final Rule.

2. Submit the OPTN Board of Directors approved OPTN Registration Fee Procedures to the COR for review within five (5) business days after OPTN Board of Directors approval.

3. Provide the services necessary for the OPTN to maintain a reserve account equal to at least four months of OPTN operating budget. The OPTN, through the Contractor, shall request COR approval for the Contractor to draw down funds from the reserve account and these funds shall be used for OPTN purposes. No funds may be drawn from the reserve account without prior COR approval.

4. As part of the OPTN budget process, provide support services to and coordinate with the relevant OPTN units, including the Finance Committee and OPTN Board of Directors, to determine and calculate the OPTN registration fees in accordance with the OPTN Final Rule.

The OPTN registration fees may represent a uniform fee for all transplant candidates, or a fee schedule with different fees for distinct categories of transplant candidates. Currently, the registration fees are a uniform fee for all transplant candidates. In ensuring the reasonableness of the proposed fees, the Contractor shall consider the following factors:

a) Historical pattern of fees and fee revisions;

b) Level of effort required to support the operations of the OPTN through this operations contract during the contract period;

c) Number of patient registrations projected;

d) Costs, and subsequent changes in costs, of providing services;

e) Accumulation of appropriate capital and operating reserves for the OPTN; and

f) Guidance from operating committees such as Policy Oversight Committee or POC and

Network Operations Oversight Committee or NOOC to determine prioritization of activities to support OPTN activities.

5. Not expend funds derived from the OPTN registration fees for any purpose other than to support OPTN contract activities as described herein

6. Support the Finance Committee with developing a detailed annual budget that aligns with the proposed activities on the project management plan (See Task 9.3).

7. Provide status updates on the OPTN budget development to the COR during weekly conference calls, and the Quarterly Reports and meetings.

8. Submit the draft OPTN Detailed Annual Budget with supporting documents electronically to the COR for review and approval within thirty (30) calendar days prior to review and approval by the OPTN finance committee. If the COR requires any changes, submit a final OPTN Detailed Annual Budget electronically to the COR within three (3) business days after receipt of COR feedback. Assist the Finance Committee in providing the COR approved OPTN detailed annual budget to the OPTN Board of Directors for review and approval.

9. Submit the draft OPTN Board of Directors Approved Annual OPTN Budget Package with a statement of the approved patient registration fee, detailed OPTN budget, and budget supporting documents such as financial analyses, registration projections justification electronically to the COR for approval no later than five (5) business days after OPTN Board of Directors’ approval. If the COR requires any changes, submit a final OPTN Board of Directors Approved Annual OPTN Budget Package electronically to the COR within three (3) business days after receipt of COR feedback.

OPTN Operations IDIQ

5.2 Financial Reporting

The Contractor shall:

1. Submit a Monthly Finance Report of revenue and expenditures associated with the OPTN contract electronically to the COR within ten (10) calendar days after the end of the reporting month. The Monthly Finance Reports shall include a statement of revenues by source of revenue (i.e., Federal government, OPTN patient registration fees) and expenses, a cash flow statement, account payables, a receivables aging statement, and a statement of transplant candidate registrations.

2. Submit Monthly Account Statements covering financial account statements for the primary and reserve accounts and for all OPTN accounts including investment accounts, if applicable, electronically to the COR within ten (10) calendar days after the end of each month. These monthly reports shall also include year-to-date summaries of the same information.

5.3 Internal Controls and Audit

The Contractor shall:

1. Provide support services to the Finance Committee to submit a draft Annual Self-Certification

Package for Internal Controls to ensure internal controls are in place that effectively and efficiently manage the OPTN operations finances electronically to the COR for review and approval within twenty (20) calendar days after the EDOC. If the COR requires any changes, submit a final Annual Self-Certification Package for Internal Controls electronically to the COR within three (3) business days after receipt of COR feedback.

2. The Self-Certification Package shall include a description of the internal control evaluation process of the Contractor, and provide a Risk Assessment description, a list of Control Objectives selected for internal review, and the total number of Internal Control deficiencies.

In addition, the Self-Certification Package shall include timelines for conducting the following activities, along with the description of each activity, in accordance with Government Auditing Standards (Yellow Book):

a) Review and update the OPTN internal controls documentation and control objectives to ensure accuracy of current processes, controls, workflow, and system interfaces, etc.;

b) Perform a Risk Assessment to identify high-risk areas within OPTN for management staff to assess the activity and determine if mitigating internal controls are necessary.

The risk assessment shall also be used to aide in the selection of those areas subject to internal audits, reviews, testing, etc.; and

c) Perform any combination of internal audits, external audits, or other tools (such as Government Accountability Office (GAO) tool entitled Internal Control Management and Evaluation Tool) to evaluate the OPTN system of internal controls.

3. Submit a Report of the Activities electronically to the COR in accordance with the timeline established in the Self-Certification Package. The Report of Activities shall include any internal control deficiencies and the status of any corrective actions plans.

6. Administrative and Coordination Services The Contractor shall provide all services necessary for the coordination and facilitation of committee, subcommittee, ad hoc groups, workgroups, and regions administrative and managerial functions. This includes service for meetings and logistics, research and analytics, management services, and access to information. Communicate outcomes of all activities to the COR, the OPTN Board of Directors or designate, and the OPTN Board of Directors support contractor.

OPTN Operations IDIQ

6.1 OPTN Meetings

The Contractor shall:

1. Promote transparency in OPTN committee, subcommittee, ad hoc and workgroup, and regional deliberations. This includes, at a minimum, providing that:

a) All OPTN meetings not identified as closed are public meetings and any person can attend or access committee, subcommittee, ad hoc and workgroup, and regional deliberations, with only sessions subject to criteria reviewed by the OPTN Board of Directors and approved by HRSA being considered closed sessions;

b) For closed sessions, there is a clear and specific justification for not being open to the public specified in the criteria referenced in (a); and

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

2. Submit a draft Annual Planning Document for providing administrative and logistical support to the committees, subcommittees, ad hoc groups, workgroups, and regions electronically to the COR for review and approval within fifteen (15) calendar days after the EDOC. The plan shall anticipate up to two (2) in-person meetings with a virtual for each policy committee and region annually and up to six (6) ad hoc virtual meetings annually, and an average of three (3) virtual subcommittees, ad hoc, and work group meetings per policy committee each month.

3. Coordinate with the OPTN Board Support Contractor and other OPTN entities to provide virtual meeting services for up to fifty (50) meetings for the OPTN Board of Directors, Executive Committee, and Nominating Committee. The Annual Planning Document shall include, at a minimum:

a) Designated point of contact/liaison for each committee, other than the Nominating Committee, and other governance groups;

b) 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;

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;

c) Frequency (dates and time with clear justifications) and mode (virtual or in person with clear justifications) based on prioritization of policy and operation activities;

d) Proposed platforms for hosting virtual meetings and virtual components of hybrid meetings. The platform(s) shall have the capability to allow participation by the public, include video capability, and be accessible to individuals with visual and/or hearing impairments;

e) 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 hybrid meeting, and ten

(10) calendar days prior to each virtual meeting; and an upon agreed timeline between the Contractor and the COR for the ad hoc meetings.

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

OPTN Operations IDIQ

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

h) Process and timeline for coordinating with relevant parties, including the OPTN operations contractor(s) responsible for communications, to post information such as meeting announcements and meeting summaries on the OPTN website (OPTN meeting announcements and summaries shall only contain information relating to activities of the OPTN);

i) Criteria for closed sessions of OPTN meetings;

j) Plan for recording and transcribing all meetings (including obtaining advance consent to recording from all attendees at each event) 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;

k) Timelines for making meeting summaries available to attendees and the public.

Meeting summaries shall be sent electronically to the COR within two (2) business days after each meeting and within five (5) business days to meeting participants, and include topics covered, decisions considered and made by the committee, and required follow-up actions including responsible parties; and

l) Structure and process to support and facilitate travel of all non-Federal members attending in-person component of hybrid OPTN meetings.

4. Submit a final Annual Planning Document addressing all COR feedback electronically to the COR for approval within five (5) business day after receipt of COR feedback.

5. Submit updates electronically to the COR as changes occur to the Annual Planning Document within five (5) business days of Contractor notice of changes.

6. Coordinate with the COR and OPTN operations contractor(s) responsible for communications to publish OPTN meeting announcements, calendars, agendas, materials, information for public participation, and meeting summaries on the OPTN website in accordance with the Annual Planning Document and provide links to the information on the OPTN website to other organizations operating websites (including professional societies, patient advocacy organizations, news outlets, or Contractor’s websites).

7. Submit recordings and transcripts of open or closed sessions within five (5) business days of receiving a request from the COR.

6.2 Document Management Platform

The Contractor shall:

1. Establish and maintain a web-based collaboration and document management platform that facilitates collaboration and document/artifact sharing among members of the OPTN. At a minimum, the platform shall:

a) enable document upload and download, storage, and search features;

b) have the capability to track document history;

c) provide ability to access documents based on roles;

d) either serve as an archive or link to an archive including all materials reviewed and deliberated on by OPTN governance groups according to meeting date;

e) comply with industry standards for security and privacy requirements; and

f) be available and accessible by the COR and other federal officials 99.9% of the time.

2. Review the platform annually and identify any proposed changes for COR approval through the annual Project Management Plan. The review shall address regular updates and proposed improvements, issues and bugs, and platform compliance with security standards and contractual requirements.

OPTN Operations IDIQ

3. Implement changes in accordance with timelines in the Project Management Plan.

7. Services to Support the OPTN Organ Center Allocation and Placement

7.1 Technical Assistance to OPTN Members

The Contractor shall:

1. Submit a draft Technical Assistance Plan documenting processes to provide technical assistance to OPTN members regarding organ procurement, allocation, transportation, and transplantation electronically to the COR for review and approval within twenty (20) calendar days of the EDOC. The Technical Assistance Plan shall include, at a minimum:

a) an approach to ensure coverage 24-hours/day, every day of the year, to OPTN members (e.g., transplant hospitals, OPOs, and laboratories) and other entities involved in the process to facilitate matching, transporting, transplantation of donated organs, and to ensure timely organ placements and reduce organ discards resulting from logistical issues in the system.

b) development of resources, visual aids, FAQ to assist OPTN members.

2. Submit a final Technical Assistance Plan addressing all COR feedback electronically to the

COR for review within five (5) calendar days after receipt of COR feedback.

3. Implement the COR approved Technical Assistance Plan.

4. Submit a Technical Assistance Monthly Progress Report on technical assistance provided the prior month electronically to the COR within five (5) calendar days after the end of each month. Monthly progress reports shall document organ placement activity resulting from the technical assistance provided (including the percentage of organs successfully placed and not successfully placed.) The report shall also include call volume, availability, and use of technical assistance and resolution success rate, segmented by support topics.

8. Contract Management

8.1 Branding

The Contractor shall:

1. Brand OPTN products (e.g., organ packaging labels, brochures, web portals) to prevent any confusion or appearance of conflicts of interest. This includes not branding any OPTN products as products of the Contractor entity or as joint OPTN/Contractor products.

Additionally, the Contractor must not brand products not produced under the OPTN as OPTN products. OPTN products must clearly be marked to indicate their status as OPTN products.

OPTN products must not include trade names of proprietary products. While contractors must brand such materials as OPTN products, the materials may include COR approved acknowledgments of Contractor work performed during the performance of this contract. The COR must approve any such acknowledgement prior to use in OPTN products.

2. Not use trade names of proprietary products in reference to OPTN activities and functions supported by this contract.

8.2 Coordination with Entities Supporting the OPTN

The Contractor shall:

1. Share all data and information necessary to enable the OPTN and all entities supporting the OPTN to successfully perform their requirements. This includes assisting with access to OPTN data, process and procedure documentation, and other data and information necessary for OPTN or OPTN Board of Directors support.

OPTN Operations IDIQ

2. Meet and collaborate monthly, or at the direction of the COR, with other contractors and entities supporting the OPTN to ensure the successful receipt, access, and usability of OPTN data or other necessary information.

3. At least monthly, or at the direction of the COR, participate in strategic planning and other meetings to coordinate, collaborate, integrate efforts, and ensure efficient tracking, prioritization, and implementation of work across all entities supporting the OPTN.

4. Continually monitor, manage, and adjust processes, procedures, and functionality to integrate work with other entities supporting the OPTN.

5. Monitor, identify, and mitigate risks and proactively inform HRSA of any issues that prevent performance or successful implementation of efforts.

6. Conduct and participate in monthly, or at the direction of the COR, retrospectives to work collaboratively with entities supporting the OPTN to identify issues and achievements, develop recommendations for improvement, and report on outcomes.

8.3 Kickoff Meeting

The Contractor shall:

1. Furnish a platform, approved by the COR, to host the virtual kickoff meeting.

2. Set up a kickoff meeting between all key personnel and the COR no later than two (2) business days after the EDOC. The kickoff meeting shall occur no later than ten (10) business days after the EDOC.

3. Submit a draft Kickoff Meeting Agenda electronically to the COR for approval at least two (2) business days before the kickoff meeting. The Kickoff Meeting Agenda shall address each of the kickoff meeting objectives.

4. The objectives of the kickoff meeting shall include the following, at a minimum:

a) Introducing key project participants and identifying their roles to initiate the communication process between the COR, other designated government officials, other HRSA contractor(s), and the Contractor;

b) Establish contract expectations;

c) Discuss proposed approach to meet the requirements under this contract;

d) Review the submitted Project Management Plan (PMP); and

e) Review invoicing requirements.

5. Submit detailed meeting minutes electronically to the COR within two (2) business days following the kickoff meeting. The meeting minutes shall include, at a minimum, a list of action items, the personnel assigned to action items, and due dates.

6. Ensure that all Contractor key personnel are present and active participants in the kickoff meeting. Active participant means, at minimum, that personnel are present and prepared to respond to questions or concerns directed at them from the COR, or other designated government officials.

8.4 Project Management Plan

The Contractor shall:

1. Submit a draft Revised Project Management Plan electronically to the COR for approval within five (5) business days after the kickoff meeting. The Initial Project Management Plan will be included in the proposal package and be the basis of the kickoff meeting discussion.

The Revised Project Management Plan shall address the recommendations provided by the COR and other COR designated government officials during the project kickoff meeting.

OPTN Operations IDIQ

2. Submit a final Project Management Plan addressing all COR feedback electronically to the COR for approval within two (2) business days after receipt of COR feedback.

3. Implement the COR approved Project Management Plan.

8.5 Weekly Conference Calls

The Contractor shall:

1. Conduct one (1) weekly conference call with the COR and other COR designated government officials to discuss the status of the activities under the contract.

2. Submit an agenda electronically to the COR before no later than one (1) business day before each call. The agenda shall follow a format approved by the COR. At a minimum, the conference call agenda shall include documentation that demonstrates project status, level of effort (LOE), timelines, risks, and mitigations to identified risks.

3. Submit a comprehensive summary of each conference call electronically to the COR within two (2) business days following the call. The conference call summary shall include at a minimum a summary of issues discussed, action items, the personnel assigned to action items, and due dates.

8.6 Ad-Hoc Meetings and Alerts

The Contractor shall:

1. Alert the COR regarding any issues related to the performance of this contract and coordinate a conference call to discuss the issues, upon request by the COR.

2. Meet with the COR, and other COR designated government officials, upon request by the

COR to discuss any issues related to this contract. Plan for an average of 5-7 ad-Hoc meetings per month during each contract year.

3. Submit an agenda that outlines the issue(s) to be discussed electronically to the COR before each call. The Contractor shall submit the agenda as soon as is practicable, depending on the ad hoc or alert situation.

4. Submit a comprehensive summary of the call electronically to the COR within an agreed upon timeline determined during the meeting. The meeting summary shall include, at a minimum, a summary of issues discussed, action items, the personnel assigned to action items, and due dates.

8.7 Quarterly Progress Reports and Contract Meetings

8.7.1 Quarterly Progress Reports

The Contractor shall:

1. Propose the draft format of the Quarterly Progress Reports to the COR for approval within thirty (30) calendar days after the EDOC. If COR requires changes, submit a final format of the Quarterly Progress Reports electronically to the COR within five (5) business days after receipt of COR feedback.

2. Submit a draft Quarterly Progress Report electronically to the COR for approval within five (5) business days after the end of the prior quarter.