Attachment_I_-_OPTN_SOW.pdf

Statement of work Revised July 9, 2013

Organ Procurement Transplantation Network

REQUIRED TASKS

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 administer the OPTN Chatter, Policies, and Bylaws; and shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities as needed to perform of its tasks as the OPTN listed below in the Statement of Work.

Task l: Establish and Maintain a Board of Directors and Committees

The Contractor shall maintain a Board of Directors and committees for the OPTN. The Contractor shall provide support for the board and committees to include: arranging meetings and teleconferences; assuring that the necessary costs of travel, meeting rooms and other expenses for the members and supporting personnel are paid; taking and disseminating minutes of the meetings; providing staff support to prepare materials, conduct descriptive analyses and provide other support as requested by the members for meetings; providing staff support to obtain OPTN membership and other input and to finalize and disseminate OPTN Policies and Bylaws based on OPTN Board decisions; and providing other staff support to the board and committee members as necessary to facilitate operations. Activities of the OPTN Board and committees shall focus on issues relating to achieving the goals of the OPTN as outlined in the OPTN Strategic Plan and OPTN final rule. Issues concerning the Contractor's non-OPTN activities shall not be addressed when the Contractor's Board of Directors performs the duties of the OPTN Board.

The Contractor shall provide updated lists including the names and the qualifications (resume, CV) of each Board member to the COR (See Delivery Item 1).

The Contractor shall submit a description of changes to its process(es) used to identify, recruit, cultivate, and select members of the OPTN board and committees to the COR (See Delivery Item 2).

1a. The Board of Directors shall elect an Executive Committee and Finance Committee from the membership of the Board.

As membership changes, the Contractor shall submit the names of Executive Committee and Finance Committee members to the COR (See Delivery Item 3).

l.b. The Board of Directors shall appoint an Executive Director of the OPTN. The Executive

Director may be reappointed upon the Board's determination that the responsibilities of this position have been accomplished successfully.

As changes occur, the Contractor shall submit the name of the Executive Director to the COR (See Delivery Item 4).

1.c. The Board of Directors shall maintain and modify as necessary an OPTN Charter and Bylaws that describe the structure and operation of the OPTN. The Charter and Bylaws shall be specific to the OPTN and shall be separate and distinct from the charter and bylaws that are pertinent to the Contractor's non-OPTN activities. The OPTN Charter and Bylaws shall encompass all aspects of OPTN operations including but not limited to:

• Organization of the OPTN;

• Membership of the OPTN;

• Transplant Program Requirements (including qualifications of transplant physicians and surgeons);

• Corrective Action and Enforcement;

• Policy and Standards Development; and

• Other areas as required by the COR.

The Contractor shall provide updates to the Charter and Bylaws approved by the Board of Directors to the COR (See Delivery Item 5).

l.d. The Contractor shall convene meetings of the Board of Directors and committees using a schedule that achieves the intended goals of this contract and the OPTN final rule. The Contractor shall provide logistics and other support functions necessary to enable the Board of Directors and committees to perform their respective tasks under this contract.

Expenses related to members (excluding federal ex-officio members) attending the meetings will be paid by the Contractor; however, members will receive no further financial compensation for their work. The Contractor shall provide the COR, the Board of Directors and/or committee members with a meeting agenda and background materials at least 2 weeks in advance of every meeting. Background materials shall include the following: background of policy proposals; discussion of rationale for policy proposals;

anticipated impact of policy proposals; and summary of comments or opinions of OPTN members and regions, OPTN committees, and the public regarding policy proposals. All Board, committee, and other workgroup meetings will be conducted in facilities that accept federal per diem reimbursement rates for travelers unless approved by the COR.

The Contractor must consult with the COR in advance of any deviations from this schedule should such deviations become necessary.

The Contractor shall provide an agenda and background materials in electronic format (unless paper specifically requested) for the Board of Directors meetings and committee meetings to the COR (See Delivery Item 6).

The Contractor shall maintain and provide to the COR a schedule of when Board and Committee meetings were held, the date meeting materials should have been provided, and the date meeting materials were actually provided to Board and Committee members (See Delivery Item 7).

l.e. The Contractor shall maintain and update a plan to increase the efficiency and productivity of the OPTN Board and committees. This plan shall address issues such as utilizing technology to facilitate board and committee member interaction in between meetings; maintaining the focus of committee and Board meeting agendas on achieving the stated goals of the OPTN; and maximizing the number and type of activities that could be performed outside of committee meetings by contractor staff. Subsequent to provision of the initial plan, updates on increasing the efficiency and productivity of the OPTN Board and committees shall be provided via each quarterly report.

The Contractor shall maintain and update its plan to increase the efficiency and productivity of the OPTN Board and committees and provide updates to the plan to the COR (See Delivery Item

8) and post them on the OPTN website.

l.f. The Contractor shall maintain and update its plan to provide ongoing communication and education to Board and committee members about OPTN-related matters. The purpose of such communication is to ensure that Board and committee members receive adequate information, education, and background on matters requiring an informed decision. This plan shall take into consideration the need to inform and educate Board members who are not transplantation professionals and shall be implemented immediately prior to Board meetings and at routine intervals during the year independent of Board and committee meetings. Updates regarding ongoing communication and education to Board and committee members about OPTN-related matters shall be provided via each quarterly report (see Task 8).

The Contractor shall provide updates to its plan for conducting routine education and communication to OPTN Board and committee members to the COR as changes occur (See Delivery Item 9).

l.g. The Contractor shall maintain procedures to identify and minimize potential conflicts of interests among members of the Board and committees respectively. The Contractor shall assure that appropriate policies and procedures are in place to prospectively identify potential conflicts and followed at all times should a conflict, or perceived conflict, arise during Board, Executive Committee, or committee deliberations. These procedures shall be specified in the OPTN bylaws. Since the technical expertise required to make informed decisions may best be obtained from those involved in organ procurement and transplm1tation, the Contractor shall implement procedures to obtain appropriate input from Board and committee member(s) under safeguards that minimize actual or apparent conflicts of interest.

The Contractor shall annually provide conflict of interest policies, procedures, and signed conflict of interests statements for all Board members to the COR and to the Contracting Officer (See Delivery Item 10).

A list identifying specific potential conflicts of interest that may arise as the result of issues on each OPTN Board meeting agenda and how the Board intends to prospectively address each potential conflict must be provided to the COR 1 week prior to each Board meeting (See Delivery Item 11).

l.h. The OPTN Board of Directors shall develop an annual set of OPTN committee goals to guide the activities and deliberations of the Board of Directors and committees. The committee goals shall be consistent with the OPTN Strategic Plan and achieving the scope of work and deliverables under this contract. These goals shall be carried out under the direction of the Board and with the assistance of the OPTN Committees. Following

Board approval, the Contractor shall provide the Board-determined annual set of OPTN committee goals to the COR and will post the goals on the OPTN website (See Delivery Item 12).

The Contractor shall submit a report detailing the OPTN's progress in achieving its annual set of goals to the COR (See Delivery Item 13).

1.i. The Board of Directors shall establish a Nominating Committee that shall have a composition similar to the Board of Directors and in developing and implementing policies and procedures for recruiting nominees that are inclusive of transplant programs, OPOs, histocompatibility laboratories, transplant organizations, transplant candidates, transplant recipients, donor families, and living donors and also reflect the public policy and public health responsibilities of the OPTN. The nominating process shall be open, and the committee shall solicit nominations from the membership for each position on the Board, except for those positions filled by reason of the holder's office (i.e., President and Immediate Past President). The Nominating Committee will take steps to assure there is more than one individual for each open position to be filled, except for those Board positions filled by reason of the holder's office. The COR and the Director of the DoT, or their designees, shall be ex-officio, non-voting members of the Nominating Committee.

The Contractor shall provide the agenda for each Nominating Committee meeting, information about each nominee, and the final slate of nominees to the COR (See Delivery Item 14).

l.j. The Board of Directors shall maintain a Policy Oversight Committee (POC) comprising vice chairs of OPTN Committees; ex officio, non-voting members of the SRTR Contractor and the Division of Transplantation of the I-IHS; and other individuals as approved by the COR for the purpose of the following:

I) Advising and supporting the OPTN Board of Directors and Executive Committee in effective planning of OPTN policy development activities, including support of the OPTN annual committee goals and strategic planning activities;

2) Reviewing and making recommendations to the OPTN Board of Directors and Executive Committee regarding proposed OPTN policies, particularly allocation policies, to ensure that proposed policies are

a. objective and measurable,

b. scientifically based,

c. consistent with NOTA, the OPTN final rule, the OPTN strategic plan, and any specific direction that may be provided by the HHS Secretary;

3) Advising the OPTN Board of Directors, Executive Committee, and other

OPTN committees on OPTN policy issues that have broad implications across OPTN committees, such as, principle for OPTN multi-organ allocation policy

. and for limiting geographic disparity in organ allocation.

l.k. The Contractor shall support the Board of Directors in establishing a Data Advisory Committee (DAC) to work jointly with the Contractor for the Scientific Registry of

Transplant Recipients (SRTR) to develop specifications for collecting data pertinent to the operation of the OPTN and SRTR, the analyses of these data, the mechanisms to be used for presenting and disseminating data and the results of data analyses and research to the general public and the research community, and the mechanisms to review requests for patient identified and identifiable data to ensure that requests comply with the terms of the OPTN final rule and the OPTN Data Release Agreement for bona fide Research and Analysis. The DAC shall comprise subject matter experts and shall not be subject to a requirement for regional representation.

1.1. The Board of Directors shall maintain permanent standing committees that shall address critical policy issues. The Contractor shall provide committee liaison staff possessing necessary expertise to support the committees. The permanent standing committees shall include, at a minimum, the following committees:

(i) Organ Specific Committees (e.g., Thoracic Committee, Liver/Intestine

Committee, Kidney Committee, and Pancreas Committee) to achieve the goals of the OPTN Board of Directors and to consider medical and scientific aspects related to organ procurement and transplantation and to develop policies consistent with equitable organ allocation as set forth in the OPTN final rule. It is essential that each committee have members possessing strong analytic skills. Organ specific committees must demonstrate effective collaboration with constituent committees such as the Pediatric, Minority Affairs, Ethics and other committees and subcommittees throughout the policy development process.

(ii) Membership and Professional Standards Committee to establish membership criteria, to establish professional standards, to monitor OPTN members for continued compliance with OPTN membership criteria, OPTN Bylaws and policies, the OPTN final rule, and to review and improve the performance of OPTN members including transplant center performance and organ procurement organization performance, and to address events identified to present a risk to patient safety.

(iii) Ethics Committee to consider ethical issues related to the process of organ procurement, distribution, and transplantation, including social impact, the relationship of cost to benefits, public trust, impact on patients and their families as well as society at large, legal issues, living donation, and related public policy and access to transplantation issues.

(iv) Patient Affairs Committee to advise the Board of Directors, other committees, and the OPTN-at-large concerning patient and donor family perspectives on proposed policies and issues.

(v) Minority Affairs Committee to identify and propose solutions for issues which impact organ procurement; access to OPTN public comment processes; access to the waiting list; allocation and transplantation of minorities; and provide input and recommendations to the Board of Directors.

(vi) Pediatric Committee to identify and propose solutions for issues relating to pediatric organ procurement; organ allocation and transplantation, including pre- and post-operative care; expeditious transplantation of children; and specific medical, social, growth, and psychological needs of children as they relate to organ transplantation.

(vii) Living Donor Committee to identify and consider issues related to donors and recipients in the transplantation of organs from living donors. Such issues include but are not limited to qualifications of living donor transplant programs; living donor safety; living donor and recipient evaluation; living donor and recipient short- and long-term follow-up.

l.m. The Board of Directors shall establish and dissolve committees, or modify the roles of committees to address changing conditions. The Contractor shall notify the COR in writing when such changes occur.

l.n. Members of OPTN committees will be appointed for set terms approved by the Board of

Directors following a public nominations process that includes input from OPTN members and a public call for nominations posted on the OPTN website. Chairpersons shall be appointed based on a process that includes input from the committee and approval by the Board of Directors. For individuals affiliated with OPTN members the selection process shall talce into account the member's institutional performance and policy compliance record. This appointment process also shall include a mechanism to limit an individual's length of service on a committee, to prevent simultaneous service on committees (unless serving as a liaison between 2 committees), and to appoint a wide range of interested individuals who can bring new perspectives to committee issues.

The Contractor shall submit an annual list of chairpersons of the committees, a list of committee members, and justifications for simultaneous service on committees to the COR and will notify the COR in writing when committee chairs change (See Delivery Item 17).

The Contractor shall maintain and update its procedures for identifying and cultivating potential committee chairpersons and members; accepting and approving nominations; and final selection of chairpersons and members of all OPTN committees, and provide such updates to the COR as they are made (See Delivery Item 18).

l.o. The COR and the Director of the Division of Transplantation, HRSA, or their designees, shall serve as (and be referred to as) ex-officio, non-voting members of all committees, subcommittees and workgroups.

1.p. The Contractor shall maintain and update its detailed committee management plan for the management of the standing committee structure, including the following elements:

(i) a list of standing committees, size, and membership;

(ii) the number of Committee meetings and/or conference calls planned for each committee during the contract period, including the meeting location;

(iii) the process by which each committee will implement the goals established by the OPTN Board of Directors, including the HHS Organ Transplantation Program performance goals;

(iv) the mechanism by which each committee's progress in meeting the goals of the OPTN Board of Directors will be publicly reported.

The Contractor shall submit updates of the committee management plan to the COR (See Delivery Item 19).

The Contractor shall maintain and update its plan for identifying and selecting non-physician representatives to OPTN committees (See Delivery Item 20).

l.q. The Board of Directors or Executive Committee shall establish and dissolve ad hoc committees, as necessary, in accordance with the OPTN Bylaws.

1.r. Any individual shall be entitled to attend those portions of committee meetings that are designated as open discussion periods. HHS representatives designated by the COR may attend any open and closed discussion periods of OPTN Board of Directors and committee meetings.

Meeting dates and locations will be provided to the COR at least one month prior to each meeting and agendas provided at least 2 weeks prior to each meeting. After this information is provided to the COR this information shall be posted on the OPTN website (See Delivery Item 21).

Meeting minutes (or summaries) and supporting materials shall be provided to the COR and posted on the OPTN website within 30 days following each board and committee meeting. The Contractor shall provide the COR with updates of its plan to notify OPTN members of the availability of these materials (See Delivery Item 22). Materials that are provided by outside parties and that are not Section 508 compliant are not required to be posted on the OPTN website.

1.s. The Contractor shall provide ongoing descriptive research support to the OPTN committees. This support shall include conducting research to address questions posed by the OPTN. Requests shall be forwarded by the OPTN staff to the OPTN COR, the SRTR COR, and to the SRTR Contractor simultaneously. Once reviewed by the committee chairperson and COR, the OPTN Contractor shall conduct the analysis and submit a written draft report to the committee chair, COR and to the SRTR for review 1 month prior to the next committee meeting. The committee chairperson, COR and the SRTR will provide comments to the Contractor, and the Contractor shall submit a final report to the committee chairperson, the COR, and the SRTR.

The Contractor shall submit an analysis plan to the COR for review and comment (See Delivery Item 23). The Contractor shall submit a draft report to the COR for review and comment (See Delivery Item 24). The Contractor shall submit a final report to the COR for review (See Delivery Item 25).

Task2: Develop, Implement, and Monitor Policies

2.a. The Board of Directors shall develop and implement OPTN Bylaws, Policies, standards, and guidelines for the operation of the OPTN. In accordance with federal law and in coordination with the COR, the Board of Directors shall be responsible for developing, with the advice of the OPTN membership and other interested parties, Bylaws and Policies within the mission of the OPTN, as set forth in Section 372 of the Public Health Service Act and 42 CFR part 121. Policies developed by the OPTN shall be separate and distinct from policies of private organizations or those that govern the Contractor's non- OPTN activities. No other policies or bylaws shall govern the operations of the OPTN.

2.b. The Contractor shall submit to the COR updates to its OPTN policy development and implementation process, including:

(i) the process to be used to assure that policies comply with the OPTN final rule;

(ii) the process to be used to promote effective collaboration and cooperation among the various OPTN committees and OPTN members;

(iii) the process to be used to gain input from OPTN members and the public

(including patients with end-stage organ failure not yet on the waiting list) on proposed policies;

(iv) the process to be used to obtain input from OPTN members using regional meetings;

(v) the process to be used (e.g., computer simulation) to test the probable effect of proposed policies, with particular emphasis on allocation policies, and the plan to interface with the SRTR Contractor and the SRTR Technical Advisory Committee (STAC) to obtain analyses to support policy development;

(vi) the process to be used to obtain input from the Policy Oversight Committee (POC); and

(vii) the process to be used to identify policies to be made enforceable under the OPTN final rule and interacting with HRSA to make policies enforceable.

The Contractor shall submit updates to its policy development and implementation process to the COR (See Delivery Item 26).

2.c. The Contractor shall update, as needed, the Evaluation Plan, its plan for monitoring and enforcing patient safety and OPTN member compliance with OPTN Obligations as defined in the OPTN Bylaws, to include survey instruments, a review process, and data systems for the purpose of:

(i) reviewing applications submitted for membership in the OPTN;

(ii) reviewing applications submitted to be designated as an organ-specific transplant program and/or kidney recovery hospital;

(iii) conducting ongoing and periodic reviews and evaluations of each member

OPO, histocompatibility lab, and transplant hospital for compliance with OPTN Bylaws, policies and applicable federal law;

(iv) conducting ongoing reviews and evaluations of OPO, transplant program and histocompatibility laboratory performance to include assessments of organ procurement and transplantation rates and graft- and patient-survival rates. Performance improvement plans must be developed and implemented in cooperation with appropriately identified programs.

(v) identifying and disseminating for adoption the practices utilized by transplant programs to achieve higher than expected graft- and patient-survival rates.

(vi) promptly receiving, from OPTN members or the general public, and reviewing reports of events representing a potential threat to patient safety as a result of any aspect of the organ procurement and transplantation process.

The Contractor shall submit updates to its evaluation plan to the COR as changes are made (See Delivery Item 27).

The Contractor shall submit to the COR upon request a report listing every OPTN member's current compliance status information including dates of the most recent site survey conducted, the type of survey conducted, a summary of any policy violations as determined by the MPSC, and violations found through allocation MPSC analysis or analysis of event handling reports.

The table will also indicate whether the member is currently being monitored for outcomes, specifically one-year post transplant outcomes, as well as whether they are being monitored for their pre-transplant metrics (See Delivery Item 29).

2.d Reserved

2.e. At the request of the Secretary, through the COR, the Contractor shall conduct special reviews of OPOs, histocompatibility laboratories, and transplant hospitals, where the Secretary has reason to believe that such entities may not be in compliance with OPTN policies and/or federal laws, or may be acting in a manner which poses a risk to the health of patients or to public safety or is inconsistent with federal law. The Contractor shall conduct these reviews in accordance with such schedules as the COR specifies and shall provide periodic reports on the progress of these reviews as the COR specifies.

The Contractor shall submit reports of special reviews to the COR (See Delivery Item 30).

2.f. Until variances are documented in OPTN policies, the Contractor shall submit to the

COR a report of existing variances including a description of the variances, as they are modified (See Delivery Item 31).

2.g. The Contractor shall submit to the COR updates to its plan for providing timely review from the Board of Directors on proposed and existing federal regulations and policies that affect the OPTN. This plan shall provide for a process to obtain input from the relevant OPTN committees, OPTN members, and the public, with the final written recommendation coming from the Board of Directors. Once this plan is approved by the COR, it shall be implemented by the Contractor. The plan shall also provide for submission of written recommendations to the COR (See Delivery Item 32).

2.h. The Contractor will conduct an evaluation of the OPTN Kidney Paired Donation Pilot

Project (KPDPP) to include analysis of the effectiveness of the KPDPP, including facilitating donor exchanges that result in successful kidney transplants, the operational costs of incorporating KPD as a permanent function of the OPTN, challenges and barriers to successful incorporation of KPD as a permanent function of the OPTN, but not including the development or administration of a Standard Acquisition Charge (SAC) for Kidney Paired Donation. If the Board of Directors concludes and the COR concurs that the KPDPP should be made a permanent activity of the OPTN, the Contractor shall operate an OPTN Kidney Paired Donation Program according to policies adopted by the Board.

Task 3: Develop, Validate, Maintain and Monitor a System to Match and Allocate Organs 24-hours/day, 365 days/year

3.a. The Contractor shall operate an operations center that will assist transplant hospitals, OPOs, and histocompatibility laboratories throughout the U.S. with matching, transporting and sharing organs. This operations center must be staffed on a 24-hours/day, 365 days/year basis. The operations center shall be equipped to permit effective and efficient communication with transplant hospitals, OPOs, and histocompatibility laboratories. The operations center also shall be equipped with computer terminals to allow staff to run the computer algorithms that match candidates with donors. In addition to the primary operations center, the Contractor shall provide for a backup operations center should the primary center become inactive. This secondary center shall be operational with minimal interruption. At a minimum, this plan shall address, as appropriate, the following issues: facility requirements (e.g., buildings);

equipment (computers, communications equipment, etc.); project time schedule; the work processes that will be used; the types and numbers of human resources; training of Contractor staff; and how operational disruptions of the operations center will be handled to assure that there is minimal disruption in the services provided by the operations center.

The Contractor shall submit any updates to the operations center's operational plans, including operational metrics to assess the performance improvement of the operations center, to the COR (See Delivery Item 33).

3.b. The Contractor shall maintain and update its work plan for the design, development, testing, installation, and documentation of an automated system that will match transplant candidates to organ donors; electronically notify transplant programs of available compatible organs; and collect data on transplant candidates, deceased and living donors, imminent and eligible donors, and transplant recipients as well as addressing, as appropriate, the following issues: facility requirements (e.g., buildings); equipment (computers, communications equipment, etc.); project time schedule; the work processes that will be used; the types and numbers of human resources; testing and validation systems; training of Contractor staff and outside clients (e.g., OPTN members);

information technology and interface requirements for OPTN member OPOs, transplant programs, and histo labs; and with vendors having contractual arrangements with OPTN members to facilitate donor referrals, organ placement, and/or data collection (in addition to the OPTN system or in lieu of a certain aspect of the OPTN system); documentation of the system including decision rules used to develop allocation matching algorithms; and operational metrics to measure the efficiency and effectiveness of processes used to program OP1N policies prior to implementation. The system shall be able to meet the following operational requirements:

(i) The system shall be capable of collecting time-critical information to list transplant candidates on organ-specific waiting lists; provide for real-time matching of transplant candidates with deceased donor organs in accordance with OP1N allocation policies 24-hours/day and 365-days/year; use information technology to speed the process of organ acceptance and eliminate organ offers to candidates incompatible with available donors; and provide timely feedback to transplant programs on any organ declined by the program that is transplanted at another program.

(ii) To promote effective use of the data systems, as well as full and accurate data submission, the Contractor will develop a five-year core competency plan. The goal is to provide end-user training that promotes effective and comprehensive use of the system by members. This will include formation of a transplant community-based advisory group and a system user group. These professionals will provide guidance. The approach will be phased with yearly objectives defined.

(iii) Development of plans for system innovations shall be a collaborative effort among the Contractor, HRSA DoT and the HRSA Office of Information Technology (OIT).

(iv) The system must provide for minimal interruption in access to the transplant candidate to donor matching system in the case of a catastrophic failure of the primary system.

(v) The system shall protect the confidentiality of patient and donor information, and only personnel with the proper clearance(s) will have access to confidential information.

(vi) The system shall protect the ranking of transplant candidates.

(vii) The OPTN's Policy shall stipulate that information regarding transplant candidates, transplant recipients, living donors, deceased donors, and imminent and eligible deaths be reported to the OPTN Contractor. The specific data collected and appropriate time frames for data collection shall be developed by OPTN Committees with the advisement of the SRTR Contractor and approved by the OPTN Board of Directors. OPTN Policies shall also stipulate appropriate data submission requirements for each category of data collected, consistent with the OPTN final rule. All data specified by the Secretary, pursuant to the OPTN final rule, shall also be collected consistent with the Secretary's specifications.

(viii) The Contractor shall maintain and make available to the COR upon request detailed documentation including a narrative description and flow charts/decision tables, etc. that fully describes the decision rules used to match transplant candidates with available organs. This documentation should be complete and sufficiently detailed to fully describe how organ allocation policies and all exceptions to these policies are implemented in the computer matching system. This documentation shall include the results of testing all allocation policies and exceptions to policies that demonstrate that the decision rules fully accomplish what is stated in policy and approved exceptions to these policies. This documentation shall be updated, including a summary of the results of all test cases, as policies and exceptions to policies change.

The Contractor shall submit organ allocation decision rule documentation and test runs to assure conformance between OPTN policies and match run outputs to the COR (See Delivery Item 34).

(ix) Algorithms for implementing organ allocation policies must be validated before being implemented in the system.

(x) The Contractor shall assure that data collection policies provide for appropriate sanctions for members that do not comply with data standards.

In addition, these policies also shall provide for timely notification about non-compliant members to the Executive Committee and the COR.

3.c. The Contractor will meet with the COR within 30 days of the effective date of the contract to discuss the plan outlined in 3.b.

The Contractor shall submit updates to its automated information system final work plan to the COR (See Delivery Item 35).

The Contractor shall submit an OPTN member-identified quarterly report of the completeness of information submitted by OPOs, transplant programs, and histocompatibility labs (to include the number of data collection forms expected and received from each program and whether form submission was within the time limits described in OPTN Policy) to the COR (See Delivery Item 36).

3.d. The Contractor shall provide logistical and staff support for a pilot study of a new electronic system to label and track organs collected and transported through the OPTN being conducted as part of the HHS Innovation project. In support of this pilot study, the Contractor shall analyze the current practice of identifying and labeling and tracking organs from procurement through transplantation, with the goal of improving the system and reducing errors. Analysis will include a failure modes and effects analysis;

identification of areas where the system is susceptible to failure; determination of how electronic intervention can reduce errors involving labeling, packaging, transport, and unintended recipient surgery. The Contractor shall create a "proof of concept" system that will allow for testing the electronic intervention; test the intervention in a simulation setting; analyze the process to determine where revisions to OPTN Policy would improve the system; and continue field testing based on results of pilot work.

Task 4: Implement and Maintain a Data Collection System and Website

4.a. The Contractor shall maintain and update its work plans that describe the design, development, testing, and installation of a computer system to support collection of data and analysis of pre- and post-transplant data, with priority being given to the use of off-the-shelf software applications whenever possible. The Contractor shall incorporate, to the extent practicable, data outside of the OPTN collected data to augment and validate the data for analysis (e.g., CMS data, Social Security Death Master File Data, etc). The plans shall maintain and keep current, as appropriate, elements addressing the following issues: facility requirements (e.g., buildings); equipment (computers, communications equipment, etc.); software; project time schedule; the work processes that will be used;

the types and numbers of human resources; testing and validation of systems; training of Contractor staff on security and confidentiality issues. Updates and progress will be reported in the OPTN Progress Report (see Task 8). The system shall be able to meet operational requirements outlined below.

(i) The system shall be capable of storing, manipulating and analyzing large volumes of data.

(ii) The system shall support the necessary software to manage data and perform the necessary complex statistical analysis.

(iii) The Contractor shall maintain and update the OPTN website for purposes of making information required by this contract to be publicly available. The Contractor will work with the COR to develop a plan for updating and improving the OPTN website (Delivery Item 37). The Contractor will work with the COR and HRSA's OIT on the details to ensure the website is compliant with the requirements specified in this contract. The website shall be updated at least monthly to permit public viewing of data reports as well as information about organ donation and transplantation. There shall be linkage to the SRTR Contractor's website, allowing individuals to search for specific data.

The OPTN website shall be separate and distinct from the Contractor's other websites. OPTN data, policies, meeting calendar and other OPTN-related information shall be posted on the OPTN website before they are posted on the Contractor's website. The OPTN website shall be compliant with Section 508 of the Rehabilitation Act of 1973, as amended in 1998, which requires that technologies developed, maintained, bought or used by federal agencies to perfmm their missions must be accessible to people with disabilities, including employees and members of the public. (See www.section508.gov) Therefore, all OPTN-related information prepared by the Contractor and posted on the OPTN website shall meet such requirements.

The system shall support the broad dissemination of data and reports to the public via the Internet. This continues, and does not change, the functionality of the current web applications. Variables of interest may include but are not limited to:

wait list registrations by transplant hospital and other units of analysis; donors and transplants by OPO, state, region and other units of analysis; donors by type (e.g., living and deceased).

(iv) All electronic information products are required to comply with relevant U.S.

Government policies, which are subject to change over the course of this contract.

These Government policies include, but are not limited to Section 508 of the Rehabilitation Act as amended, OMB guidelines (http://www.whitehouse.gov/omb/memorandalfy2005/m05-04.pdf).

Domain name. The OPJN website is a continuation of the current OPJN website and does not need to be hosted on a HRSA server, since there are special concerns that favor hosting outside the agency. However, the domain name must have a ".gov" URL. The contractor will work with the COR and HRSA's OIT to achieve this standard.

Section 508. All federal websites must be compliant with Section 508 of the Rehabilitation Act of 1973, as amended, effective June 21, 2001 and thereafter.

Federal websites in this context include any and all sites owned or operated by the agency and/or developed and/or maintained with Federal funds (See www.section508.gov).

HRSA Template. Websites developed for HRSA must have the HRSA look and feel. HRSA OIT will make available a Dreamweaver template that comprises the design elements and the footer links that must be included on all HRSA web pages.

Department Identity. All web pages developed for HRSA shall identify HRSA, its parent and the U.S. Department of Health and Human Services. The sponsoring HRSA program may also be identified, but no other corporate identity (e.g., logo, icon) is allowed.

External Links. All links to non-U.S. Government Websites should be clearly identified with a disclaimer. Relevant information sources in the government space must be provided before commercial links are provided and the use of links to commercial sites must be minimal and justified.

Email. All web pages must provide an email link to the HRSA e-Service Center (<http://answers.Ju·sa.govIcgi-bin!hrsa.cfg/php/enduser/std alp.php?p sid=-- 3J9Fwg&p lva=&p sp=&p li>=) where users may view frequently asked questions and post their own questions regarding the content or operation of the website.

Persistent Cookies. All HRSA websites are prohibited from using persistent cookies for any purpose.

http://www.whitehouse.gov/omb/memorandalfy2005/m05-04.pdf) http://answers.ju/ http://answers.ju/

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(v) The Government's and Contractor's respective rights in the system and data are as described in Section I.

4.b. The Contractor shall meet with the COR within 90 days of the effective date of the contract to discuss the website plan outlined in 4.a. Based on discussions with the COR, the Contractor shall revise and implement the existing website work plan as mutually agreed and provide a revised plan to the COR if needed.

The Contractor shall submit updates to the website work plan as needed (See Delivery Item 37).

4.c. The Contractor shall identify national data sources outside of the OPTN that can legally be incorporated into the data system, in order to further validate and extend data collected by the OPTN. With the prior approval of the COR, the Contractor shall procure and maintain such data sources. The Contractor also shall explore other potential national data sources of data in order to improve and extend the quality of the data for which analysis is based. The Contractor shall identify the need for and submit to the COR draft documents of data use agreements required to procure such data. Before such data may be used for analysis, all issues of human subject protection must be addressed consistent with the HHS regulations for protection of human subjects at 45 CFR part 46.

4.d. In addition to the operational requirements that will be addressed in the work plan discussed in task 3.b., the Contractor shall assure that the following requirements are met.

(i) In making data available to the public, the Contractor shall make available manuals, forms, flow charts, operating instructions, or other explanatory materials as necessary to understand, interpret, and use the information accurately and efficiently;

(ii) The Contractor shall assure that OPTN policies require each OPO and transplant program to maintain such records pe1taining to transplantation-related matters that the Department deems necessary to carry out its responsibilities under the NOTA, as amended, and other relevant legislation and regulation (the OPO and transplant program shall maintain these records for seven years) as communicated to the Contractor in writing by HRSA, including but not limited to each potential donor identified, each organ offered and the outcome of each offer, each organ retrieved, each recipient transplanted, and the outcome of each transplant;

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(iii) Any OPTN data collected by the Contractor, including patient-level data, shall be provided to the COR or his/her designee upon request.

(iv) The collection of data is subject to clearance by the Office of Management and

Budget (OMB). The Contractor shall adhere to OMB clearance requirements and shall prepare the necessary draft OMB clearance documents, as requested including submission of data to be collected, the frequency of collection, the burden hours imposed by the new collection, the rationale for the new data collection elements or forms, the currently approved collection forms, and any other OMB required information. Documents used for the collection of data shall be submitted to HRSA for final review and submission to OMB. Prior to such submission to HRSA, modifications to the data to be collected by the OPTN data system shall be approved by the OPTN Board of Directors after consulting with relevant committees of the OPTN, the SRTR, and the COR. The Secretary may also modify the data elements to be collected by the OPTN data system.

(v) The Contractor shall comply with the requirements of the agency computer security program to the extent that the Contractor's costs incurred as a result of changes to the requirements of that program do not exceed the amount of such costs included in the annual OPTN budget approved by the OPTN Board of Directors.

4.e. The Contractor shall provide and maintain an application and technology architectural roadmap that addresses further OPTN system needs based on the requirements of this contract and the goals established by the OPTN Board of Directors. The plan shall include enhancements to the current system by incorporating new and improved technology to increase efficiency, data accuracy, organ matching and placement, and better overall effectiveness of the OPTN. The plan should focus on how technology can be used to achieve the requirements of this contract and the goals established by the OPTN Board of Directors.

Once it has been approved by the OPTN Board of Directors, the Contractor shall submit the application and technology roadmap to the COR (See Delivery Item 39).

4.f. The OPTN Contractor shall participate in a small joint OPTN/SRTR data quality technical working group, comprising representation from the staff of the OPTN Contractor, and the staff of the SRTR Contractor. This task force shall discuss the contents of a data quality report prepared by the SRTR contractor and make recommendations for a final SRTR quarterly report with recommendations to resolve any data quality issues, if necessary. It is expected that most, if not all issues of data quality would be resolved either via telephone conference or email. It is not required to include HRSA staff on telephone conferences in the preparation of the quarterly report.

Task 5: Respond to Data Requests

5.a. The OPTN Contractor shall release data consistent with its obligations set forth in the OPTN final rule and the procedures under SECTION H - SPECIAL CONTRACT REQUIREMENTS, H.8. Data Release Policy, shall, upon request, make available to the COR data reports based on specifications provided by the COR to include the types of media (e.g., paper, spreadsheet, etc). Upon request, the Contractor shall provide through the COR, or directly to the HHS requester with the knowledge of the COR, any or all of these data to components within the Department on a need-to-know basis. Data requests shall be fulfilled within 30 days of request from the COR, unless a written extension is requested and approved by the COR. [Note that data may not be subject to disclosure for reasons set forth in H.8] Government data requests shall be given the highest priority of all data requests.

A listing of all government data requests shall be provided in the quarterly report to the COR (see Task 8).

The Contractor shall respond to data requests from the COR (See Delivery Item 40).

5.b. The Contractor shall update and maintain its plan detailing the process by which it will manage prioritization, responses, and charges for non-government requests for data.

The Contractor shall submit to the COR updates to its data request management plan for non-government data requests, (See Delivery Item 41) and will post the plan on the OPTN website.

5.c. The Contractor shall maintain its data release policies to be consistent with SECTION H-

SPECIAL CONTRACT REQUIREMENTS, H.8, Data Release Policy, including policies related to the release of data to OPTN members, other academic and non-academic institutions, and the general public. Any distribution of data or analyses must include protection consistent with the Privacy Act, the Trade Secrets Act, the FOIA, and other statutory and regulatory policies. Policies are to be kept current and developed in accordance with the policy development process established by the Board of Directors.

The Contractor shall implement updates to the plan, submit updated data release policies to the COR (See Delivery Item 42), and post them on OPTN website.

Task 6: Initiate the OPTN Deceased Donor Potential Study

The Contractor shall be responsible for the OPTN Deceased Donor Potential Study. This research study shall be conducted to the maximum extent feasible by the OPTN Contractor staff in conjunction with qualified subject matter experts and may include appropriate co-investigators from both the transplant and non-transplant communities. This study will replace the three research projects originally proposed but not completed due to competing priorities and budget constraints. HRSA requests to approve contractor staff proposed as principal investigators(s) for the study. Revised deliverables for Task 6 are as follows:

(i) Submission of an overall project plan including proposed OPTN contractor staffing (1 month post-award)

(ii) Submission of a proposed list of Stakeholder Committee members as developed with input from HRSA and schedule for meetings (2 months post-award)

(iii) Stakeholder Committee meetings (quarterly: 2 in-person meetings per year; at least one in Washington, DC/Rockville and 2 conference calls per year)

(iv) Submission of annual project plan for the second year of study activity (1 year post-award)

(v) Submission of written quarterly status repm1s (4, 8, 12, 16, 24 months post-award)

(vi) Preliminary models for…