Attachment_A_-_SOW_Scientific_Registry_of_Transplant_Recipients.doc

Attachment A

Performance Work Statement (PWS)

Scientific Registry of Transplant Recipients (SRTR)

5/26/2015 Version 1.0 3Vision Statement

1 Introduction

1.1 Mission

1.2 Background

1.3 Scope

1.4 Period of Performance

2 General Requirements

2.1 Contract Administration and Management

2.2 Subcontract Management

2.3 Contractor Personnel, Disciplines, and Specialties

3 Performance Requirements

3.1 Transition Plan

3.2 Contract Administration Requirements

3.3 Establish and Maintain SRTR Specific Committees

3.4 Security and Privacy Requirements and SRTR Web Sites

3.5 SRTR Data Management

3.6 Access to the SRTR Data

3.7 Analytic Support

3.8 Simulated Allocation Models (SAMs)

3.9 Program-specific Reports (PSRs)

3.10 Publications

3.11 Optional Tasks

4.1.1 Security and Privacy Requirements Annex

4.6.2 Quality Assurance Surveillance Plan (QASP)

Performance Work Statement (PWS) Scientific Registry of Transplant Recipients (SRTR) Vision Statement

To provide advanced statistical and epidemiological analyses related to solid organ allocation and transplantation in support of the Department of Health and Human Services (HHS) and its agents in their oversight role of the national organ transplantation system.

1 Introduction

The Division of Transplantation (Program), Healthcare Systems Bureau, Health Resources and Services Administration (HRSA) is seeking a contractor to operate the Scientific Registry of Transplant Recipients (SRTR). The Contractor will be responsible for providing statistical and other analytic support to the Organ Procurement and Transplantation Network (OPTN) for purposes including the formulation and evaluation of organ allocation and other OPTN policies. Additionally, the Contractor will provide analytic support to HHS in a variety of areas including: policy formulation and evaluation, system performance metrics, economic analysis, and preparation of recurring and special reports to Congress.

1.1 Mission

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

1.2 Background

Section 373 of the Public Health Service (PHS) Act requires the operation of the SRTR to support ongoing evaluation of the scientific and clinical status of solid organ transplantation. The U.S. Congress passed the National Organ Transplant Act (NOTA; P.L. 98-507) in 1984. The act established the OPTN to maintain a national registry for organ matching. The OPTN final rule (42 CFR Part 121) provides a framework for the structure and responsibilities of the OPTN. One of the major responsibilities of the OPTN is the development of policies that determine how donor organs are allocated to transplant candidates. The OPTN final rule requires that these policies be based on sound medical judgment and reviewed periodically and revised as appropriate. It is the primary responsibility of the SRTR Contractor to provide the analytic support and evidence necessary to support the OPTN in the development and evaluation of OPTN policy. Although, the SRTR Contractor is substantively involved in the policy development process, it is the responsibility of the OPTN and not the SRTR Contractor to develop OPTN policies. The OPTN Contractor is responsible for primary data collection and providing OPTN data to the SRTR contractor on a monthly basis. The OPTN database contains information on waitlist registrants, transplant recipients, and deceased and living donors since 1987. The size of OPTN database continues to expand given the tremendous demand for organ transplants. Approximately 29,000 organ transplants were performed in the U.S. in 2013. As of December 31, 2014, there were approximately 123,851 individuals with end-stage organ failure awaiting organ transplants in the U.S. The demand for organs for transplants far surpasses and will continue to surpass the number of organs donated each year. There is a clear need for improvements in matching donor organs with recipients and the monitoring and evaluation of transplant outcomes.

1.3 Scope

The Contractor will be responsible for working closely with the OPTN and the contractor for the OPTN on data collection, analysis and quality improvement activities. The OPTN Contractor is responsible for primary data collection and providing these data to the SRTR on a regular basis. The OPTN collects data for each major event in the transplant process including: patient registration on the transplant waitlist, transplant procedure or removal from the transplant waitlist, and periodic follow-up of both transplant recipients and living donors following transplantation. The OPTN also collects information about the organ donor and the disposition of organs retrieved from each donor. The SRTR is responsible for storage, maintenance and protection of these data, supplementing these data with available external data sets to develop ongoing analytic datasets for the purpose of conducting analyses in support of the OPTN and HRSA, and for making a subset of these data available for bona fide research.

The SRTR Contractor shall serve as the primary analytic resource to the OPTN and HHS. The SRTR contractor shall provide analytic expertise to support analyses of a broad range of issues relating to: waitlist and post-transplant outcomes evaluation; the evaluation of existing OPTN policies; the likely impact of proposed OPTN policies; and the operation and performance of the OPTN as a whole and of its various members. The performance of this contract requires the Contractor to establish and maintain a collaborative working relationship with the OPTN Contractor, the various committees and members of the OPTN, and other entities within HHS such as the Centers for Medicare and Medicaid Services (CMS), the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control (CDC), the National Center for Health Statistics (NCHS), the Secretary’s Advisory Committee on Organ Transplantation (ACOT), and other members of the transplant community. In the performance of this contract, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities needed to perform the tasks described in this Performance Work Statement (PWS). Most of the data required to perform these tasks shall be those collected by the OPTN Contractor and provided to the SRTR Contractor on a periodic basis, but will also include other datasets to be procured by the SRTR Contractor to help validate and supplement the OPTN data.

1.4 Period of Performance

The period of performance for the SRTR contract is five years (September 21, 2015-September 20, 2020) with one base year and four option years.

2 General Requirements

2.1 Contract Administration and Management

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

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

2.2 Subcontract Management

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

2.3 Contractor Personnel, Disciplines, and Specialties

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

3 Performance Requirements

3.1 Transition Plan

3.1.1 The Contractor shall develop a transition plan and complete the transition from the existing SRTR Contractor within 90 days after the effective date of the contract (EDOC).

Within 21 days after the EDOC, the Contractor shall submit an updated transition plan to address any comments from the COR on the plan proposed in the technical proposal. Once approved by the COR, the Contractor shall implement the transition plan that addresses receipts of materials from the predecessor contractor; scheduling meeting with predecessor contractor to discuss data, programming transfer, analytical activities of the SRTR and its current support for OPTN committees, and continuity of services during transition. The Contractor shall notify COR when materials transfer has been completed. The Contractor shall complete the transition within 90 days after the EDOC.

Within 14 days after contract award, the COR will provide the Contractor with a list of the materials developed and procured using contract funds including web application programming, data, programming, documentation and reports, and external data procured under the contract. The materials will also include Simulated Allocation Models (SAMs) and associated input data sets, allocation rules, programming sources codes and documentation.

Performance Standards

a) STD: Transition plan includes action plan to receive contract materials, meeting with predecessor contractor to ensure continuity of services. Transition plan also includes a completion timeline.

b) STD: The updated transition plan is submitted within 21 days after the EDOC.

c) STD: The transition is completed within 90 days after the EDOC.

Deliverables D01 Updated transition plan D02 Meeting agenda D03 Status updates on the transition via email D04 Written notification to the COR upon the completion of the transfer of contract materials

3.1.2 The Contractor shall execute a formal written agreement for data transfer with the OPTN contractor.

The Contractor shall execute a formal written agreement with the OPTN Contractor to arrange for the monthly transfer of all data collected under the OPTN contract. The formal agreement shall address the terms of agreement for the transfer of the OPTN data, including data transfer schedule, mode of transfer and encryption method. The COR shall approve the terms of the agreement between the contractors for data transmission before implementation.

Performance Standards

a) STD: The agreement is executed within 30 days after the EDOC.

b) STD: The terms of agreement include data transfer schedule, mode of transfer, and encryption method used.

Deliverables D05 Formal written agreement with the current OPTN contractor for data transfer

3.2 Contract Administration Requirements

3.2.1 The Contractor shall develop a strategic plan consistent with the scope of work and performance period of this contract.

The Contractor shall develop a strategic plan consistent with the scope of work and performance period of this contract, and set short and long term goals in alignment with the strategic plan. The plan and goals shall be submitted to the Steering Committee (Task 3.3.1) for review and to the COR for approval.

Performance Standards

a) STD: Strategic plan is consistent with the scope of work and performance of the contract. Short and long term goals are in alignment with the strategic plan.

b) STD: Strategic plan is provided to the Steering Committee for review during annual meeting.

c) STD: Strategic plan is submitted to the COR within 14 days after the Steering Committee meeting.

D06 Strategic plan

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

The Contractor and key personnel specified by the COR in consultation with the Contractor shall hold two conference calls per month to discuss current issues related to the contract. The Contractor shall provide meeting agenda and minutes.

Performance Standards

a) STD: Meeting agenda is sent two days prior to the call for COR's feedback.

b) STD: Meeting minutes are submitted to COR within seven days after the call.

Deliverables D07 Project conference call agenda D08 Minutes of project conference call

3.2.3 The Contractor shall attend joint meetings for the SRTR and OPTN contractors.

SRTR and OPTN CORs, and representatives of the SRTR and OPTN contractors, and other appropriate Federal government staff, as determined by the CORs, shall meet in person at least twice a year at HRSA to discuss the status of tasks and issues concerning data collection and analysis. The COR will schedule meeting dates in consultation with Federal Government staff and the SRTR and OPTN contractors. The contractor shall submit agenda items for the meetings.

Performance Standards

a) STD: Meeting agenda items are submitted to COR for review at least 14 days prior to meeting date.

D09 Joint SRTR and OPTN CORs and contractors meeting agenda items

3.2.4 The Contractor shall submit quarterly progress reports on the status of the contract performance.

The Contractor shall submit written progress reports to the COR at the end of each quarter. These reports shall describe the status of tasks, upcoming committee meetings, number of SAF (Task 3.6.1) and SAM (Task 3.8.3) requests, number of data requests from outside the Government (Task 3.6.3) and data quality issues reported to OPTN monthly (Task 3.5.2).

Performance Standards

a) STD: Quarterly progress reports are submitted within 30 days after end of each reporting period.

b) STD: Quarterly progress reports include

· status of tasks

· a calendar of the upcoming committee meetings

· the number of SAFs and SAMs data requests

· the number of routine and complex data requests from outside the Government

· summary of data quality issues

D10 Quarterly written progress reports

3.2.5 The Contractor shall submit, for COR review and approval, requests from outside organizations to attend meeting or give presentation as SRTR Contractor.

The Contractor shall submit written requests for COR review and approval. The request shall include a synopsis of the purpose of the presentation and an overview of the organization and its role in the field of organ transplantation.

Performance Standards

a) STD: Contractor submits written request within seven days of receiving request.

D11 Written request for participation in meeting or give presentation as SRTR contractor

3.2.6 The Contractor shall conduct a briefing for the COR and other appropriate Government staff.

The Contractor shall brief the COR and other appropriate Government staff in person to discuss accomplishments and lessons learned. The Contractor shall provide recommendations on improvements to the SRTR structure and processes to increase efficiency and effectiveness of the SRTR contract.

Performance Standards

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

b) STD: Recommendations focus on areas in SRTR structure and processes that can be improved to increase efficiency and effectiveness of the SRTR contract.

Deliverables D12 In-person briefing to the COR and other appropriate Government staff D13 Briefing materials including recommendations

3.2.7 The Contractor shall submit an analytical support plan to provide analytical support to the OPTN Board of Directors and committees.

The Contractor shall consult with the OPTN Contractor to assess the level of analytical support required by the OPTN Board of Directors and over twenty committees (see http://optn.transplant.hrsa.gov/converge/members/committees.asp for a list of the committees, and attached OPTN Statement of Work for committee responsibilities). The Contractor shall assign staff with appropriate training, experience, and credentials to provide analytical support to the OPTN committees.

The Contractor shall work with the OPTN Contractor to develop a mutually agreed process for submitting reports in response to data requests from the OPTN committees, subcommittees and working groups that takes into account the meeting schedule and the frequency of subcommittee and working group conference calls.

The Contractor shall submit the analytical support plan including a list of SRTR support staff and describing the report submission schedule within 90 days after the EDOC. The CORs of both OPTN and SRTR contracts shall approve the plan.

Performance Standards

a) STD: Analytical support plan includes analytical and clinical support staff with training, experiences, and credentials in medicine, biostatistics, epidemiology and programming to address the need of the OPTN committees.

b) STD: Analytical support plan includes process and schedule for providing reports in response to data requests by OPTN committees.

c) STD: OPTN contractor is in agreement with the proposed analytical support plan.

d) STD: Analytical support plan is submitted to the COR within 90 days after the EDOC.

D14 OPTN committee analytical support plan

3.2.8 The Contractor shall jointly with OPTN Contractor support the OPTN Data Advisory Committee (DAC).

The DAC is an ad hoc OPTN Committee that meets in person at least twice a year, see Task 1.k in attached OPTN Statement of Work for the purpose of DAC. The SRTR Contractor shall jointly with the OPTN Contractor support the committee including submitting nominees to serve on the DAC and reviewing patient identified data requests from external researchers.

Performance Standards

a) STD: Nominees for DAC members have clinical and analytical expertise appropriate for the mission of the committee.

b) STD: The Contractor works with the OPTN contractor to develop process to jointly review external requests for patient identified datasets and submits the process within 90 days after the EDOC.

c) STD: The Contractor assigned staff will attend DAC in person meetings twice a year.

Deliverables D15 Review process for patient identified datasets D16 List of nominees for DAC membership

3.2.9 The Contractor shall assign two staff to serve as ex-officio non-voting members of the OPTN Policy Oversight Committee (POC).

The POC is an OPTN Committee that meets in person at least twice a year, see Task 1.j in attached OPTN Statement of Work for the purpose of POC.

Performance Standards

a) STD: The Project Director and Deputy Project Director will serve on POC and attend POC in-person meetings twice a year.

D14 OPTN committee analytical support plan

3.3 Establish and Maintain SRTR Specific Committees

3.3.1 The Contractor shall establish and maintain a steering committee.

The Contractor shall establish a Steering Committee to provide guidance on strategic planning and project prioritization. The Contractor shall ensure OPTN analytical needs are taken into consideration by including OPTN Contract COR, the Project Director of the OPTN contract and designated OPTN representatives on the Steering Committee. The Contractor shall submit a document describing the Steering Committee membership, role and responsibilities of its members.

Performance Standards

a) STD: The Contractor shall submit a document describing the Steering Committee membership, role and responsibilities of its members within 90 days after the EDOC.

b) STD: The Contractor consults with OPTN contractor to include the staff who can assist in identifying OPTN analytical needs on the Steering Committee.

D17 Documentation of steering committee structure and roles and responsibilities and membership

3.3.1.1 The Contractor shall facilitate meetings of the Steering Committee.

The Contractor shall schedule an in-person meeting in the Washington D.C. area in the beginning of each contract year to review the SRTR plan for the upcoming year. The Contractor shall be responsible for scheduling the meetings, preparing the agenda and background materials, and providing minutes of the meetings.

Performance Standards

a) STD: Meeting is scheduled at least 60 days prior to the meeting.

b) STD: Meeting is scheduled in the first quarter of each performance period.

c) STD: Meeting materials are distributed at least 14 days before each meeting to participants.

d) STD: Meeting materials include the strategic plan, goals for the year, and updates on major tasks of the contract.

e) STD: Meeting minutes are submitted to COR within 14 days after the meeting.

Deliverables D18 Steering Committee meeting agenda and background materials D19 Steering Committee meeting minutes

3.3.2 The Contractor shall establish and maintain a SRTR Visiting Committee to advise the SRTR, the OPTN Board of Directors and OPTN committees.

The contractor shall ensure that the Visiting Committee is composed of 8 to10 members with qualifications in the areas of clinical, statistical and epidemiological research. A member of the Visiting Committee shall serve as either Chair or Vice-Chair of DAC.

A representative of the OPTN Contractor who is familiar with the data collected by the OPTN shall serve as an ex-officio member. The Chair of POC shall serve as an ex-officio member. In addition, other Federal representatives, with relevant expertise, may attend Committee meetings and serve as ex-officio members.

The Contractor shall review Visiting Committee Charter developed by the predecessor contractor(http://www.srtr.org/Stac/charters.aspx) with the Visiting Committee and make modifications.

The Contractor may establish subcommittees and/or working groups, such subcommittees or working groups may be permanent, standing committees or ad hoc. The Contractor shall provide a statement of purpose for each subcommittee and working group and a list of its members to the COR. The COR or his/her designee, shall serve as ex-officio, non-voting members on all subcommittees and working groups that may be established.

Performance Standards

a) STD: Charter previously developed is reviewed and modified.

b) STD: Qualifications of the Visiting Committee members include clinical, statistical, and epidemiological research related to transplantation, economics, simulation and analytics for predictive modeling.

c) STD: Clinicians have training and experience in transplant issues dealing with the kidney/pancreas, liver and thoracic organs, and serve currently or have previously served on the OPTN organ-specific committees.

d) STD: The statement of purpose demonstrates the need to constitute subcommittee and working group.

e) STD: Qualified experts are selected to serve on the subcommittee or working groups.

Deliverables D20 Visiting Committee Charter D21 List of members of the Visiting Committee with CV for each committee member D22 Statement of purpose for each subcommittee and workgroup under the Visiting Committee D23 List of members with a CV for each subcommittee and workgroup

3.3.2.1 The Contractor shall facilitate meetings of the Visiting Committee.

The Contractor shall convene two face-to-face meetings of the Visiting Committee each year, one of the meetings shall be held in Washington D.C. area. The Contractor shall determine the location of the other meeting based on cost and ease of access for the members. The Committee shall meet via conference call no more than twice a year. The Contractor shall provide all administrative support necessary for the functions of the Visiting Committee and its subcommittees. Travel expenses of Visiting Committee members (excluding Federal members) attending Visiting Committee meetings shall be paid by the Contractor; however, Visiting Committee members shall receive no further financial compensation for their work. The Contractor shall provide the COR and the Visiting Committee members with a meeting agenda and background materials in advance of each Visiting Committee meeting. The Contractor shall submit the minutes after each meeting.

Performance Standards

a) STD: Meeting is scheduled at least 60 days prior to each meeting.

b) STD: Meeting materials are distributed at least seven days prior to each meeting.

c) STD: Meeting minutes are submitted to COR within 30 days after each meeting

Deliverables D24 Visiting Committee meeting agenda and background materials D25 Visiting Committee meeting minutes

3.3.2.2 The Contractor shall ensure Committee deliberations do not constitute an apparent or actual conflict of interest for its members.

Since the technical expertise required to make informed decisions is best be obtained from those involved in organ procurement and transplantation, the Contractor shall implement procedures to obtain appropriate input from Visiting Committee members under safeguards that prevent actual or apparent conflicts of interest. The Contractor shall require the Visiting Committee members to disclose conflict of interest annually and certify to the COR each year that such conflicts do not exist in the deliberations and decisions of the Visiting Committee. The Contractor shall ensure that procedure is in place and followed at all times should a conflict of interest arise during Visiting Committee meetings.

Performance Standards

a) STD: Submit documentation of procedure to address conflict of interest within 120 days after the EDOC.

Deliverables D26 Conflict of interest certificate for each of the members of the Visiting Committee D27 Documentation of procedures to address conflict of interest

3.4 Security and privacy requirements and SRTR web sites

3.4.1 The Contractor shall implement and maintain security and privacy requirements for protection of data in compliance with Federal, HHS, and HRSA security and privacy requirements.

The Contractor shall ensure secure data management with appropriate level of security authorization to safeguard all data obtained under this contract. It is the Contractor's responsibility to obtain the authority to operate (ATO) from HRSA and maintain security authorization.

Within 30 days after the EDOC, the Contractor shall meet with HRSA Office of Information Technology (OIT) to discuss security and privacy requirements. The contractor shall submit documentations requested by OIT. HRSA OIT reviews the security documents, assessment results and scan reports to make sure that the security and privacy controls are in compliance with all Federal laws and regulations related to security and privacy requirements. See HRSA security requirements specified in Annex (Section 4.1.1).

Performance Standards

a) STD: Meet with HRSA OIT Security within 30 days after the EDOC.

b) STD: Submission of documentations requested by HRSA OIT to demonstrate compliance with security and privacy requirements within 90 days of request.

c) STD: Data management is in compliance with Federal, HHS, and HRSA security and privacy requirements as specified in Security and Privacy Requirements Annex (Section 4.1.1)

Deliverables D28 Documentations requested by HRSA OIT D29 Security authorization package

3.4.2 The Contractor shall maintain and improve SRTR websites for dissemination of transplant information to the public and the transplant community.

The Contractor shall maintain three web sites. The SRTR web sites do not need to be hosted on a HRSA server. The contractor shall disseminate for free over the internet (www.srtr.org) timely and accurate program-specific information on the performance of transplant programs, in compliance with the reporting requirements in 121.11(b) of the Final Rule.

The Contractor shall maintain a private secure web site (securesrtr.transplant.hrsa.gov) for data review and program specific report preview by transplant programs and Organ Procurement Organizations(OPOs) prior to public posting. The Contractor shall develop procedure to provide access to the secure web site to designated transplant program and OPO staff within 120 days of EDOC. The Contractor shall submit annual request to HRSA OIT to renew the Secure Socket Layer(SSL) certificate for the website.

The Contractor shall maintain the http://srtr.transplant.hrsa.gov website for the purposes of making Annual Data Report (ADR) and other reports produced under this contract publicly available. The Contractor shall work with the COR and HRSAs OIT to ensure the website is in compliance with all the Federal and HHS requirements.

The Contractor shall develop a plan to improve and enhance the www.srtr.org website and submit the plan to Steering Committee for review and COR for approval. The Contractor shall implement the plan after COR approval.

Performance Standards

a) STD: The contractor submits secure site access procedure to allow only designated transplant program and OPO staff access to secure SRTR website within 120 days after the EDOC.

b) STD: The Contactor submits the website improvement plan including the purpose of improvement, the resources required and the time line for completion within 180 days after the EDOC.

Deliverables D30 SRTR secure website management procedure documentation D31 Websites improvement and enhancement project plan

3.5 SRTR Data Management

3.5.1 The Contractor shall create Standard Analysis Files (SAFs) and develop an operations manual to document the work processes in generating the SAFs.

The Contractor shall create SAFs that incorporate data collected by the OPTN as well as calculated analytical variables. The Contractor shall develop SAF operations manual to document the work processes from receiving data monthly from the OPTN Contractor to creating and updating SAFs, and including developing an electronic data dictionary to describe the source, format and definition of the data elements contained in the SAFs.

Performance Standards

a) STD: The Contractor submits SAF operations manual within 180 days after the EDOC.

b) STD: The Contractor submits SAF on CD to COR quarterly.

Deliverables D32 SAF operations manual D33 Quarterly SAF

3.5.2 The Contractor shall provide a monthly data quality report to the OPTN contractor.

The Contractor shall implement procedures to evaluate the quality of OPTN data provided by the OPTN Contractor. The Contractor shall provide a data quality report monthly to the OPTN Contractor. The Contractor shall include a summary of data quality issues in the quarterly progress report provided to the COR.

Performance Standards

a) STD: Data quality report documents discrepancies, errors, missing data, and other quality data testing and validation procedures.

D34 Monthly Data Quality Report to the OPTN Contractor

3.5.3 The Contractor shall identify data sources outside of the OPTN for incorporation into the SRTR database in order to validate and enhance data collected by the OPTN.

The Contractor shall obtain CMS data and link these to the data obtained from the OPTN Contractor, primarily to supplement OPTN data with information on end-stage renal disease (ESRD) patients. The Contractor shall submit a Data Use Agreement to CMS to obtain Medicare data under Memorandum of Agreement between HRSA and CMS (HSB1100401/CMS IA 11-39).

The Contractor shall identify other available external data sources to address research questions important to the organ donation and transplantation that require data beyond OPTN collection. The Contractor shall identify the needs, necessary Data Use Agreements and costs to procure such data. The Contractor shall ensure that the external data procured under the SRTR contract can be transferred to subsequent SRTR Contractors. Before such data can be used for analysis, all issues of human subject oversight must be addressed for the use of the procured data, either by getting HRSAs Human Subject Committees exemption to include the use of these procured data, or by securing approval from an IRB, other than HRSA. The SRTRs database shall be able to segregate the data obtained from different sources (e.g., data from the OPTN as opposed to data obtained from other sources), as necessary, in order to comply with the Privacy Act, applicable System of Records notices, and applicable Data Use Agreements.

Performance Standards

a) STD: Ensure Data Use Agreements with external sources allow the transfer of data subsequent SRTR Contractor.

b) STD: Human subject oversight issues are addressed for the use of the data from external data sources.

Deliverables D35 Signed Data Use Agreement with CMS D36 Signed Data Use Agreements and/or Memorandum of Agreement for non-OPTN data

3.5.4 The Contractor shall continue to update linkages with cancer registries.

The Contractor shall continue to update the linkages or prepare finder files for cancer registries to do the linkage updates (http://www.cancer.gov/newscenter/newsfromnci/2011/OrganTransplantCancerRisk). It is estimated that about 5 updates will be performed each year.

Performance Standards

a) STD: The Contractor shall notify the COR within 30 days after each update.

D37 De-identified copy of the linked database provided to NCI and notification to the COR

3.5.5 The Contractor shall implement a process to archive historical datasets and programming codes for long-term retention during performance of the contract.

The Contractor shall implement a process to maintain historical datasets and programming codes that are important to retain for future references. The Contractor shall ensure these stored archives can be easily located and retrieved. The Contractor shall submit a document describing the process within 90 days after the EDOC.

Performance Standards

a) STD: The process covers all major analytical tasks performed under the contract, including frequency and location of the archives.

b) STD: The Contractor submits a document describing the archiving process within 90 days after the EDOC.

c) STD: Status updates on list of materials archived 30 days prior to the end of each performance period.

Deliverables D38 Document describing archiving process D39 Status updates of archived materials

3.6 Access to the SRTR data

3.6.1 The Contractor shall make SAFs available to the scientific community for research.

According to Final Rule 121.11, "the Scientific Registry, as appropriate, shall respond to reasonable requests from the public for data needed for bona fide research or analysis purposes, to the extent that the OPTN's or Scientific Registrys resources permit, or as directed by the Secretary. The OPTN or the Scientific Registry may impose reasonable charges for the separable costs of responding to such requests. Patient-identified data may be made available to bona fide researchers upon a showing that the research design requires such data for matching or other purposes, and that appropriate confidentiality protections, including destruction of patient identifiers upon completion of matching, will be followed. All requests shall be processed expeditiously, with data normally made available within 30 days from the date of request; and the Contractor shall respond to reasonable requests from the public for data needed to assess the performance of the OPTN or Scientific Registry, to assess individual transplant programs, or for other purposes. The OPTN or Scientific Registry may impose charges for the separable costs of responding to such requests. An estimate of such charges shall be provided to the requester before processing the request. All requests should be processed expeditiously, with data normally made available within 30 days from the date of request”.

The Contractor is to be reimbursed by the researchers for the cost of the SAFs. The Contractor shall provide technical assistance in utilization of the data. The contractor shall require the researchers to complete the Data Use Agreement developed by HRSA for both OPTN and SRTR Contractors. The Contractor shall submit request for data with Personally Identifiable Information (PII) to COR for review and approval. The Contractor shall track the number of SAF requests and report this information in the quarterly progress report.

Performance Standards

a) STD: The instructions for how to request SAFs, file layouts, data dictionaries, and the cost information for SAFs and technical assistance are posted on the SRTR public web site within 180 days after the EDOC.

b) STD: SAFs requests not involving PII are processed within 30 days after the date of the request.

c) STD: SAFs requests involving PII are processed according to the review process for patient identified datasets developed under Task 3.2.8.

Deliverables

D40 Data requests requiring release of PII

3.6.2 The Contractor shall respond to data requests from within the Federal Government within specified schedule.

The Contractor shall make available to the COR data reports based on format and media specifications (e.g., paper, electronic, spreadsheet, etc.) provided by the COR. The Contractor shall provide data reports (through the COR) to components within Federal Government. Data requests shall be fulfilled within 30 days of request from the COR, unless a written extension is requested and approved by the COR. Some data requests involve data that may be withheld under the terms of the Privacy Act of 1974, as amended (5 U.S.C. ' 552a), the Trade Secrets Act (18 U.S.C. ' 1905), the Freedom of Information Act (FOIA) (5 U.S.C. ' 552), or other applicable laws. For example, any personally-identified or personally identifiable data maintained in the OPTN/SRTR/HRSA Data System of Records, HHS/HRSA/HSB/DoT, No. 09-15-0055, including data maintained electronically, must be disclosed consistent with the Privacy Act and the Systems Routine Uses, outlined in the applicable System of Records Notice (73 Fed. Reg. 19519, as amended).

The contractor shall notify the COR within three days of the request if: (1) the data are not collected and/or verified; (2) release of the data violates the Privacy Act or applicable laws; (3) the use of the data is not sufficiently valuable to warrant a large scale expenditure of time and effort; or (4) the data and information are otherwise exempted from disclosure under the FOIA, when applicable.

Data requests from within the Federal government shall be given the highest priority of all data requests.

Performance Standards

a) STD: Federal Government data requests are fulfilled within 30 days after request.

D41 Data report or data files produced in response to data requests from COR

3.6.3 The Contractor shall respond to data requests from outside the Federal Government within established timeline.

The Contractor shall respond to routine data requests within 30 days of receipt and to more complex requests within 60 days of receipt. If it will take more than the allotted time to respond to either type of data request, the Contractor shall notify the requestor of the amount of time required to fulfill the data request. Fees may be charged to non-Federal entities to cover the reasonable costs of providing data or data analyses. The Contractor shall track the number of routine and complex data requests from outside the Government and report this information in the quarterly progress report.

Performance Standards

a) STD: Respond to data request within the allotted time.

AQL: Complex requests may take more than 60 days to respond; however, Contractor shall notify the requestor of the amount of time required to fulfill the data request.

b) STD: The instructions for how to make a data request, description of different types of data requests, and the cost of fulfilling the data request are posted on the SRTR public web site within 120 days after the EDOC.

3.7 Analytic Support

3.7.1 The Contractor shall provide analytic support to the OPTN Board of Directors, OPTN committees, subcommittees, and working groups.

The SRTR contractor shall work with OPTN committee liaison in developing OPTN request for analysis. The request for analysis will be submitted by the OPTN committee liaison to the COR and the SRTR Contractor after approval by the committee chair. In response to the analysis request, the Contractor shall submit an analysis plan to the COR and the OPTN liaison for feedback. The Contractor shall submit a written report and a presentation based on the report to the COR and the OPTN liaison prior to OPTN committee meeting.

Performance Standards

a) STD: The analysis plan includes the question(s) to be answered, the cohort to be analyzed, proposed method, and the time line for completing the analysis.

b) STD: Analysis plan, written report and presentation submitted within schedule specified in the analytical support plan developed under Task 3.2.7.

Deliverables D42 Analysis plan to COR and OPTN liaison D43 Written report to COR and OPTN liaison D44 Presentation slides to COR and OPTN liaison

3.7.2 The Contractor shall provide analytic support to HRSA.

Analytic support includes support to ACOT. The Contractor shall work with the COR to specify analytic need. Once the analytic need has been finalized, the Contractor shall submit an analysis plan to the COR within 15 days. Once approved by the COR, the Contractor shall conduct the analysis and submit a written report and a presentation to the COR.

Performance Standards

a) STD: The Contractor submits an analysis plan within 15 days of request.

b) STD: Analysis plan includes the question(s) to be answered, the cohort to be analyzed, proposed method, and the time line for completing the analysis.

c) STD: Report and presentation are submitted according to the time line in the analysis plan.

Deliverables D45 Analysis plan for HRSA request D46 Written report for HRSA request D47 Presentation slides for HRSA request

3.7.3 The Contractor shall conduct a feasibility analysis and develop a plan to establishing a living donor registry.

The Contractor shall conduct a feasibility analysis of establishing a living donor registry to study the long-term outcomes of living organ donation. The contactor shall complete the analysis within nine months from the EDOC. The analysis plan shall include a project timeline with milestones. The Contractor shall submit status report to COR to monitor the progress of the analysis.

Performance Standards

a) STD: The feasibility analysis plan shall address:

1. identification of donor cohort

2. development of consent form

3. frequency of follow-up

4. development of survey instruments and data collection forms to monitor the intermediate to long term development of comorbidities and serious events

5. assessment of psychosocial and socioeconomic consequences of donation

6. methods of data collection

7. detailed estimates of the first year start-up cost and subsequent annual operating cost

b) STD: The Contractor submits the analysis plan within 30 days after the EDOC.

c) STD: The Contractor meets the milestones established in the analysis plan.

d) STD: The Contractor submits the final report nine months after the EDOC.

Deliverables D48 Analysis plan D49 Status Report D50 Report on living donor registry feasibility assessment

3.7.4 The Contractor shall analyze the geographic variations in kidney allocation.

The contactor shall complete the analysis within 12 months after the EDOC. The Contractor shall submit an analysis plan to the COR for review before commencing the study. Once approved by the COR, the Contractor shall conduct the analysis. The Contractor shall provide status reports. The Contractor shall submit a report to the COR upon completion of the analysis.

Performance Standards

a) STD: Analysis plan includes:

· a brief summary of the research problem/question and its importance to the field of organ donation and transplantation,

· the proposed hypothesis to be tested

· the methodological approach to be used

· timeline and milestones

b) STD: The Contractor submits the analysis plan within 30 days after the EDOC.

c) STD: The Contractor provides status report quarterly.

d) STD: The Contractor submits the report within 12 months after the EDOC.

Deliverables D51 Analysis plan D52 Status report D53 Report on geographic variation in kidney allocation

3.8 Simulated Allocation Models (SAMs)

3.8.1 The Contractor shall develop and implement a schedule to maintain up to date input files and allocation rules in SAMs.

Existing SAMs include: Liver Simulated Allocation Model (LSAM); Thoracic Simulated Allocation Model (TSAM) for heart and lung; and Kidney/Pancreas Simulated Allocation model (KPSAM). The purpose of these models is to estimate the potential impact of a change in OPTN policy on the various outcomes of the waitlist candidates and transplant recipients. To the extent feasible, the models shall attempt to address the requirements in the 121.8(c) of the Final Rule including assessing impact on organ procurement and access to transplantation, effect of allocation policies on programs performing different volumes of transplants, and the performance of OPOs.

Performance Standards

a) STD: The Contractor submits the schedule within 120 days after the EDOC.

b) STD: SAM input files and allocation rules are kept up to date in order to provide timely analysis based on current data and current rule.

Deliverables D54 Schedule for updating SAMs, input files, and allocation rules D55 Updated SAMs

3.8.2 The Contractor shall submit and implement plan for enhancement of the SAMs to support the analytical needs of the OPTN.

The Contractor shall submit a plan to enhance SAMs. The plan shall include the purpose of enhancements, additional capabilities provided, resources required and projected time line. SAM shall continue to be organ-specific. Once approved by the COR, the Contractor shall implement the plan.

Performance Standards

a) STD: SAM enhancement introduces new capabilities to better provide analytical support for OPTN policy development.

b) STD: SAM enhancement plan is submitted within 180 days after the EDOC.

c) STD: Enhancement is completed within specified schedule.

Deliverables D55 Updated SAMs D56 Plan for enhancement of the SAMs

3.8.3 The Contractor shall make SAMs available to researchers for bona fide research.

The Contractor shall make SAMs available to researchers to test for meaningful changes in allocation rules. The Contractor shall make available for distribution the most current version of the SAMs on compact disk (CD) at no cost. However, the Contractor shall be reimbursed by the researchers for the cost of technical assistance. The Contractor shall provide a summary of the request in the quarterly progress report.

Performance Standards

a) STD: The instructions for how to request SAMs, file layouts, data dictionaries, and the cost information for SAMs and technical assistance are posted on the SRTR public web site within 120 days after the EDOC.

b) STD: SAMs requests are processed within 30 days after the date of the request.

3.9 Program-specific Reports (PSRs)

3.9.1 The Contractor shall develop PSRs on the performance of transplant programs and Organ Procurement Organizations (OPOs).

The Contractor shall disseminate for free over the internet the timely and accurate program-specific information on the performance of transplant programs according to 121.11(b) of the OPTN Final Rule. This information shall be updated no less frequently than every six month based on the most current data provided by the OPTN Contractor. The transplant program information shall include waitlist data, pre-transplant outcomes, acceptance and utilization of organs, and post-transplant outcomes. The OPO information shall include organ donation, recovery and discards. Transplant programs and OPOs with better or worse outcome shall be identified. The Contractor shall post reporting schedule, risk-adjustment models and description of technical methods on the web site.

Performance Standards

a) STD: The transplant program and OPOs performance information includes at a minimum:

Pre-transplant waitlist data- The number of candidates on the waiting list as of the beginning of the reporting period, number of candidates added, number of candidates removed from the list and reasons for removal stratified and reported by demographic and clinical information (e.g., gender, age, race/ethnicity, blood type, etc.).

Pre-transplant waitlist outcome- The probabilities of receiving a transplant (e.g., percent transplanted within a given time frame), and dying or being removed from waitlist while awaiting transplant and other outcome measures such as overall survival following listing, and the morbidity and functional impairment of transplant candidates if available.

Post-transplant outcome- The number of recipients receiving transplants by organ type in the time period stratified by demographic and clinical information. Outcomes of multi-organ transplants shall be reported. Post-transplant outcome includes risk-adjusted information for graft and patient survival following the transplant. Long-term outcomes beyond one year shall be reported. Other outcome measures such as morbidity and functional impairment of transplant recipients post- transplant shall be considered if available.

Acceptance and utilization of organs- Acceptance and utilization rate of organs from donors of various characteristics (e.g., kidneys from donor age >65, DCD donors)

Organ donation, recovery and discards- The number of eligible potential deceased donors, deceased donors, organs recovered for transplants and discards, by organ type, stratified by appropriate demographic and clinical information such as race/ethnicity, age, blood type, etc. This information is risk- adjusted for donation rate and number of organs transplanted.

Cost and resource utilization data by transplant program

Living donor outcome - the number of living donors by organ type stratified by demographic and…