Attachment A - PWS-SRTR.pdf

Performance Work Statement (PWS)

June 26, 2020

Scientific Registry of Transplant Recipients (SRTR)

I. BACKGROUND

The Scientific Registry of Transplant Recipients (SRTR) is mandated under the National Organ Transplant Act (NOTA) of 1984, as amended. The SRTR is authorized under 42 U.S.C. 274a.

The authorization stipulates: "the Secretary shall, by grant or contract, develop and maintain a scientific registry of the recipients of organ transplants...." Although there have been several amendments to NOTA over the years, the authorizing statute for the SRTR has remained the same.

The work conducted under the SRTR is also guided by Organ Procurement and Transplantation Network (OPTN) regulations (known as the “final rule”), 42 CFR 121, as amended. The OPTN final rule was initially published in 1999. The SRTR contractor provides advanced statistical and simulation modeling support to the OPTN, the HHS Secretary’s Advisory Committee on Organ Transplantation ACOT, and the Division of Transplantation, Healthcare Systems Bureau, Health

Resources and Services Administration (HRSA). The contractor also provides independent statistical and epidemiological analyses on waitlist and post-transplant data collected by the

OPTN contractor. The contractor develops program-specific reports to provide timely and accurate information on the performance of Organ Procurement Organizations (OPOs) and transplant programs. The contractor has also worked to improve the speed, effectiveness, and transparency of the SRTR simulation modeling that supports OPTN organ allocation policy-making by working to modernize the Liver Simulated Allocation Model (LSAM); Thoracic

Simulated Allocation Model (TSAM) for heart and lung; and Kidney/Pancreas Simulated Allocation model (KPSAM).

II. GENERAL DESCRIPTION

In performance of this contract, HRSA requires that the SRTR Contractor be responsible for providing statistical and other analytic support to the OPTN for purposes including the formulation and evaluation of organ allocation and other OPTN policies. Additionally, the Contractor shall provide analytic support to HRSA in a variety of areas including: policy formulation and evaluation; system performance metrics; economic analysis; and preparation of recurring and special reports to Congress.

In the performance of this contract, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities as needed to perform its tasks as listed below in the Performance Work Statement. The Government shall monitor the Contractor’s performance under this contract in accordance with the contractor’s proposed and accepted Quality Assurance Surveillance Plan

(QASP).

III. PERIOD OF PERFORMANCE/PLACE OF PERFORMANCE

The period of performance shall be a base period of twelve months and four (4) twelve-month option periods. The option periods under this contract may be exercised in accordance with Federal Acquisition Regulation (FAR) clause 52.217-9 Option to Extend the Term of the Contract (MAR 2000). The period of performance under this contract shall commence with the effective date of the contract. The work will be performed off site, primarily at the location of the contractor’s site.

IV. TASKS

Task 1 Records Management

The Contractor shall manage and maintain official OPTN data and official SRTR data, as defined in

Task 2.3 below. The Contractor shall include electronic records, ensuing from this contract in accordance with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to: the Federal Records

Act (44 U.S.C. Chapters 21, 29, 31, 33); NARA regulations at 36 CFR Chapter XII Subchapter B (https://www.ecfr.gov/cgi-bin/text-idx?SID=5a883267581274fa5acf46b215245c56&mc=true&tpl=/ecfrbrowse/Title36/36CXIIsubchapB.tp l); NARA Bulletin 2013-02, August 29, 2013, Guidance on a New Approach to Managing Email Records (https://www.archives.gov/records-mgmt/bulletins/2013/2013-02.html); and NARA Bulletin

2010-05 September 08, 2010, Guidance on Managing Records in Cloud Computing Environments (http://www.archives.gov/records-mgmt/bulletins/2010/2010-05.html).

Managing the records includes maintaining records to retain functionality and integrity throughout the records full lifecycle including: (1) maintenance of links between records and metadata, and (2) categorization of records to manage retention and disposal, either through transfer of permanent records to NARA or deletion of temporary records in accordance with NARA-approved retention schedules.

1.1 Records Management Training

Records Management Training: The contractor (and/or subcontractor) shall ensure that all employees having access to (1) Federal information or a Federal information system, or (2) personally identifiable information (PII), complete the HRSA Records Management Training before performing work under this contract, and thereafter completing the annual refresher course during the life of the contract. The training can be requested by emailing the records management team at recordsmanagement3@hrsa.gov.

The listing of completed training shall be included in the first progress report. Any revisions to this listing as a result of staffing changes shall be submitted with next required progress report.

Task 2 Administration of Contract

2.1 Contract Administration and Management

The contractor shall:

Prepare a Work Breakdown Structure (WBS) establishing clear organizational lines of authority, https://www.ecfr.gov/cgi-bin/text-idx?SID=5a883267581274fa5acf46b215245c56&mc=true&tpl=/ecfrbrowse/Title36/36CXIIsubchapB.tpl https://www.ecfr.gov/cgi-bin/text-idx?SID=5a883267581274fa5acf46b215245c56&mc=true&tpl=/ecfrbrowse/Title36/36CXIIsubchapB.tpl https://www.ecfr.gov/cgi-bin/text-idx?SID=5a883267581274fa5acf46b215245c56&mc=true&tpl=/ecfrbrowse/Title36/36CXIIsubchapB.tpl https://www.archives.gov/records-mgmt/bulletins/2013/2013-02.html http://www.archives.gov/records-mgmt/bulletins/2010/2010-05.html mailto:recordsmanagement3@hrsa.gov responsibility, and resources to ensure effective management of contract requirements.

Update the WBS for each option period and provide this to the COR for approval with 10 business days of the beginning of each option period.

Acknowledge government requests within one business day.

Establish a primary single point of contact between the Government and Contractor and notify the Government of this individual and his/her contract information at Effective Date of Contract

(EDOC) and upon any change.

2.2 Contractor Personnel and Specialized Staff Recruitment Plan

Provide to the COR for review and approval within 5 business days after EDOC and beginning of each option period a recruitment plan for hiring qualified personnel and specialized expert staff with education, training, and experience specifically identified to meet the requirements of the contract.

2.3 Execute formal written agreement for official OPTN data transfer and develop and implement plan for real-time access to official OPTN data with the OPTN contractor.

The Contractor shall:

Execute a formal written agreement with the OPTN Contractor to arrange for the transfer and eventual real-time access to all official OPTN data collected under the OPTN contract. While official SRTR data consists of data collected directly by the SRTR pursuant to the SRTR

Contract, including data collected on OMB-approved forms for the Living Donor Registry, official OPTN data consists of data that are pertinent to the operation of the OPTN, necessary for the development of evidence-based OPTN policies, and necessary to support analytic work undertaken by the OPTN Contractor or the SRTR contractor. The formal agreement shall address the data transfer schedule, mode of transfer, encryption method, and eventual real-time access to official OPTN data. The COR shall approve the terms of the agreement between the contractors for data transmission before implementation.

Work with the OPTN contractor to develop a plan to move from the monthly data transfer to real-time access to official OPTN data prior to the end of this contract. The COR shall approve the terms of the plan for real-time data access before implementation.

2.4 Develop strategic plan

The Contractor shall develop a strategic plan consistent with the scope of work and full performance period of this contract, and set short and long term goals for each contract period. The plan and goals shall be submitted to the COR for review 20 business days prior to the first SRTR Review Committee (SRC) meeting of the base and option periods. Feedback from the SRC shall be incorporated and a final draft shall be submitted to the COR for approval within 14 days after the SRC meeting. The strategic plan should be reviewed and refined for each option period of the contract upon COR request.

2.5 Contract meetings with the COR to discuss current issues relating to the contract

The Contractor and individuals specified by the COR in consultation with the Contractor shall hold a conference call once every two weeks to discuss current issues related to the contract. The Contractor shall provide meeting agenda and minutes.

2.6 Participate in joint meetings with the OPTN contractor

Meet in-person with the OPTN Contractor, the OPTN COR, and the SRTR COR up to twice each fiscal year (FY) at HRSA (5600 Fishers Lane, Rockville, MD) to discuss and report on the coordination of activities between the two contractors.

Work with the OPTN Contractor, the OPTN COR, and the SRTR COR to identify dates for the meetings within ten (10) business days of beginning of each FY.

Work with the OPTN Contractor to develop the meeting agenda.

Annually as part of a joint OPTN SRTR COR meeting, the Contractor shall:

o provide to the OPTN Contractor the names of potential candidates for the OPTN Data

Advisory Committee (DAC), and o discuss with the OPTN Contractor, in support of the OPTN DAC, additions and deletions of the official data elements collected by the OPTN, recommendations to improve completeness and accuracy of data collected, and recommendations to enhance the official OPTN data with elements from other data sources..

2.7 Quarterly progress reports

The Contractor shall submit written progress reports to the COR within 30 days of the end of each quarter. These reports shall describe the status of tasks, a schedule of upcoming committee meetings, number of Standard Analytical Files (SAF) and Simulation Allocation Model (SAM) requests, number of data requests from outside the Government, and data quality issues reported to OPTN monthly.

2.8 Financial and Ad hoc Reporting

The Contractor shall prepare reports to keep the COR aware of progress and problems in the implementation of the contract:

a. Financial Reporting. On a monthly basis (12/year), the Contractor shall submit a breakdown of costs by Task numbers and Sub-tasks indicating dollars spent and dollars available as part of the monthly voucher submission.

b. Meeting Summaries. Submit meeting summaries 10 days after each meeting according to the COR.

c. Ad-hoc Reporting. Respond to ad-hoc requests from the COR to prepare written reports on a prompt response basis (e.g. 24-48 hours) on activities pertaining to the contract.

2.9 Presentations to outside organizations.

The Contractor shall notify the COR when the Contractor plans to presenting to outside organizations, and provide an overview of the outside organizations and their role in the field of organ transplantation, in advance of each presentation. Notice shall be provided at least 20 business days in advance of each presentation to allow the COR and the Contractor to resolve any issues.

2.10 Conduct briefings for the COR and other appropriate Government staff

Brief the COR and other appropriate Government staff virtually or in person when requested by HRSA (but no more than two in person meetings at HRSA offices per contract period will be required) to discuss accomplishments and lessons learned.

Provide recommendations, when requested, on potential improvements to the SRTR structure and processes to increase efficiency and effectiveness of the SRTR contract.

These meetings/briefings are distinct from the Joint COR meetings described in task 2.6.

Task 3 Analytic Support

3.1 Develop OPTN Analytical Support Plan for the provision of analytical support to the OPTN

Board of Directors, operating and policy committees, subcommittees, and working groups

Consult with the OPTN Contractor to develop an OPTN Analytical Support Plan (ASP). The ASP should assess the level of analytical support required by the OPTN Board of Directors and committees.

Assign staff with training, experience, and credentials relevant to issues addressed by each OPTN committee, subcommittee, and/or working group being supported. Staff expertise should include, but not be limited to, data analytics, biostatistics, and clinical practice relevant to the assigned OPTN committee, subcommittee, and/or working group, and these assignments should be documented in the ASP.

Collaborate with the OPTN Contractor to develop a mutually agreed-upon process and schedule, described in the ASP, for submitting SRTR reports in response to requests from OPTN committees, subcommittees, and/or working groups. This process and schedule should take into account OPTN committees, subcommittees, and/or working groups meeting and conference call schedules so that SRTR reports are provided to OPTN groups 5 business days prior to in-person meetings and 2 business days prior to conference calls. The ASP should include a schedule for mutually-agreed to meetings between the Contractor and the OPTN to discuss and coordinate

SRTR activities in support of the OPTN.

Submit the ASP to the CORs of both the OPTN and SRTR for approval by both CORs.

3.2 Implement the OPTN Analytical Support Plan to provide support to the OPTN Board of

Directors, OPTN operating and policy committees, subcommittees, and working groups

Respond to requests from OPTN groups according to the final approved ASP.

Collaborate with OPTN contractor staff in developing requests for analytic support from the

OPTN per the approved ASP. The OPTN Contractor shall simultaneously submit OPTN requests for analytic support to the SRTR COR and the SRTR Contractor.

Submit a written report and a presentation based on the OPTN request for analytic support to the COR and OPTN contractor staff prior to the relevant OPTN meeting according to the timeframes agreed to in the ASP.

3.3 Provide analytical support to HRSA

Provide analytic support to HRSA DoT and the Advisory Committee on Organ Transplantation

(ACOT).

Collaborate with the COR to develop and clarify analytic requests. The Contractor shall:

o Produce an analysis proposal for approval by the COR within 7 days of the analytic request being developed;

o Conduct the analysis and submit a written report and a presentation to the COR, upon approval of the analysis proposal by the COR.

Provide a written report and presentation to the COR within 10 business days after completion of the analysis.

Task 4 Establish and maintain a SRTR Review Committee to advise the SRTR contractor, the OPTN

Board of Directors, and OPTN committees

Develop an SRTR Review Committee (SRC), previously identified as the SRTR Visiting Committee, to provide objective expert review of SRTR contract activity, including methodological and analytical activity.

Ensure that the SRC includes members with expertise in the areas of clinical transplant practice, statistical science and methodology, simulation modeling, epidemiological research, operations research, human-centered design, transplant recipient concerns, potential transplant recipient concerns, organ procurement, donor family concerns, living donor data collection, and living donor concerns.

The Contractor shall develop, for COR approval, a plan to identify the appropriate areas of expertise needed on the SRC, a process to identify and recruit SRC members, convene SRC meetings, document SRC expert review of Contractor activities, and report to the COR on the effects of SRC review on Contractor activities in each quarterly report.

Review, with the SRC, the Charter developed for the prior SRTR Visiting Committee and make modifications if the majority of the SRC votes in favor of modifications.

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

4.1 Plan and facilitate meetings of the SRTR Review Committee

Convene a meeting each quarter of the SRC. Two of the meetings shall be face-to-face meetings to be held in Washington, DC, except in the case of a public health emergency. Two of the meetings shall be virtual.

Provide all administrative support (development of the agendas, facilitation of the meetings, and coverage of expenses for committee members to the extent permitted by Federal Acquisition Regulation (FAR) Part 31 at each meeting) necessary for the functions of the SRC and its subcommittees.

Provide logistical and administrative support, develop background materials for the pre-meeting and onsite meeting, and arrange for onsite recording of meeting notes.

Provide a summary report of the meeting, including meeting highlights, discussions, recommendations, and participant evaluations of the meetings within 45 days after each meeting.

4.2 Ensure SRC deliberations do not constitute an apparent or actual conflict of interest for its members

The Contractor shall undertake activities, including but not limited to the following, to mitigate the risk of conflicts of interest among members of the SRC. The Contractor shall:

Develop with the COR, and to be approved by the COR, an attestation document to be signed by all SRC members annually. The attestation document will acknowledge each SRC member’s understanding that they may not take into consideration any responsibilities they may have to the Contracting organization and any other organizations as they carry out their SRC responsibilities.

Obtain a signed copy annually of the attestation document by all members of the SRC and provide copies of these attestation documents to the COR.

Notify all potential SRC members that the government requires such an attestation before they can serve on the SRC.

Task 5 Identify metrics to assess national transplantation system performance and support informed decision-making by critical audiences

During the base period of the contract, the Contractor shall develop a plan to:

Identify information of interest to critical audiences that need information to assess organ procurement, transplantation, and the procurement and transplantation system. Audiences include, but are not limited to:

o patients with End Stage Organ Disease who are not yet listed for transplantation, o transplant candidates on the OPTN waitlist, o family members or caregivers of patients and candidates, o potential living donors, o potential living donor organ transplant recipients, o deceased donor families, o transplant professionals, o transplant programs and hospitals, o organ procurement organizations, o the OPTN, o third-party reimbursement entities, and o the federal government.

Develop assessments and metrics of procurement and transplantation system performance that monitor the information of interest to these critical audiences, in conformance with the public reporting requirements of the OPTN final rule.

The plan should include details on convening focus groups, consensus conferences, and other activities to identify the information of interest to critical audiences. The plan shall also include a process for developing and evaluating the metrics that are determined to be most useful and relevant for decision making by the critical audiences.

Metrics identified should include assessments of:

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 outcomes- 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, as well as other outcome measures such as overall survival following listing, and the morbidity, functional impairment and quality of life of transplant candidates.

Post-transplant outcomes- The number of recipients receiving transplants by organ type stratified by demographic and clinical information. Short- and long-term risk-adjusted information for graft and patient survival following the transplant. Outcomes of multi-organ transplants, as well as other outcome measures such as morbidity, functional impairment, and quality of life for transplant recipients post- transplant.

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)

Living donor outcomes - the number of living donors by organ type stratified by demographic and clinical information (e.g., age, gender, race/ethnicity, and comorbidities), and outcomes related to the donation (e.g., death, re-hospitalization, re-operation and other complications as data is available).

Organ donation, recovery and discards - risk-adjusted numbers of potential deceased donors, actual deceased donors, organs recovered for transplant, organ discards, by organ type, stratified by appropriate demographic and clinical information such as race/ethnicity, age, blood type, etc.

System performance - measurements of process variables reflecting patient and family engagement with the transplant system, assessment of patient and family education and support resources, as well as assessment of transplant center internal processes used to determine the information of most use and value to specific patients and their caregivers.

The Contractor’s plan shall be submitted by the end of the base year. The plan shall include a national consensus conference or conferences to determine, in an open and transparent process, the final combination of metrics to be used to assess transplant center and organ procurement organization performance by the Contractor in the SRTR reports identified in task 6 of the contract, as well as other SRTR vehicles identified for dissemination of system performance information. The Contractor shall identify risks and challenges for implementation of these metrics and propose solutions to mitigate any potential risks identified.

Following national identification and agreement on system performance metrics, the Contractor shall develop and maintain an evaluation component to monitor and assess the metrics calculated to assess accuracy, validity, and relevance to critical audiences. The Contractor’s plan shall include an open and transparent national meeting every third year engaging critical audiences to review the results of the evaluation process and reconfirm or revise the national system performance metrics.

The Contractor shall review the plan with the SRC and submit the plan to the COR for approval. The

Contractor shall implement the plan after COR approval. Should the regulations that govern OPO performance be changed, the Contractor will update the plan to conform to regulatory changes.

Task 6 Produce transplantation and organ procurement performance reports

The Contractor shall produce and disseminate for free over the internet, via an SRTR webpage

(currently https://www.srtr.org/reports-tools/program-specific-reports/) timely and accurate information on the performance of transplant programs and organ procurement organizations according to 121.11(b) of the OPTN final rule.

6.1 Transplant program-specific performance reports (PSR)

Report performance of transplant programs according to 121.11(b)(iv) of the OPTN final rule.

Reports shall be published every six months based on the most current data provided by the OPTN Contractor as well as other external data sets that may be necessary to ascertain information to assess transplant system performance. The SRTR COR must approve use of external data sets.

Post reporting schedule, risk-adjustment models and description of technical methods on the SRTR web site.

https://www.srtr.org/reports-tools/program-specific-reports/

Prior to the completion of Task 5 of this contract, the Contractor shall:

Continue producing PSRs based on metrics established in the prior SRTR contract.

Following completion of Task 5 of this contract, the Contractor shall.

Develop a new PSR presenting the metrics identified through the Task 5 process.

6.2 Produce organ procurement system performance reports

Disseminate for free over the internet timely and accurate information on the performance of organ procurement organizations (OPO) including risk-adjusted information an organ donation, recovery, and discards. This information shall be updated every six months based on the most current data provided by the OPTN Contractor as well as other external data sets that may be necessary to ascertain information to assess transplant system performance. Use of external data sets must be approved by the SRTR COR.

Post reporting schedule, risk-adjustment models and description of technical methods on the SRTR web site.

Prior to the completion of task 5, and any OPO regulatory requirement changes instituted by the Centers for Medicare and Medicaid Services (CMS), the Contractor shall:

Continue producing OPO reports based on metrics established in the prior SRTR contract.

Following completion of task 5, and any modifications to CMS regulatory requirements, the Contractor shall:

Revise the OPO reports to reflect the outcomes of task 5 and any new CMS OPO regulatory framework.

6.3 Submit plan for developing risk-adjusted models used in performance assessment reports

Describe on the SRTR website the variables and methods used in developing and evaluating any risk adjustment models used in each release of SRTR performance reports.

Provide a detailed report on variables and methods to the COR one week prior to the release of each SRTR performance report.

Task 7 Maintain and improve SRTR websites for dissemination of transplant information to the public and the transplant community.

Maintain a web sites or websites to maintain information for patients, families, and professionals that is relevant to their specific interests. The SRTR web sites do not need to be hosted on a

HRSA server. Content of SRTR websites should be informed by outcome of task 5.

Seek voluntary feedback from the public visitors to the SRTR websites on the usefulness of the website presentation.

Maintain a private secure web site (securesrtr.transplant.hrsa.gov) for data review and report preview by transplant programs and Organ Procurement Organizations (OPOs) prior to public posting.

Develop a procedure to provide access to the secure web site to designated transplant program and OPO staff within 120 days of EDOC.

Submit an annual request to HRSA Office of Information Technology (OIT) to renew the Secure Socket Layer (SSL) certificate for the website.

Maintain the SRTR http://srtr.transplant.hrsa.gov website for the purposes of making the Annual OPTN/SRTR Data Report (ADR) and other reports produced under this contract publicly available.

Work with the COR and HRSA’s OIT to ensure the website is in compliance with Task 16 requirements.

7.1 Create online data review tools

The contractor shall submit, for COR approval, a plan to create and implement online data review tools to:

allow for user-friendly access to SRTR-developed PSRs that enables the user to select among multiple variables of interest for the stratification of transplant program and OPO performance;

and provide patient-specific assessments of a patient’s personal and clinical information to help inform patient decision-making regarding transplantation treatment options (guided by the results of task 5), contingent on legal review of specific elements of this feature..

7.2 Add information on living donation to the SRTR website

The Contractor shall submit a plan for developing, implementing, and maintaining a living donor resource page on the SRTR website that contains updated information on the SRTR Living Donor Registry, as well as resources or links to resources for potential or existing living donors on topics such as: long term health outcomes of living donation; financial resources; living donor and family support resources; behavioral and mental health support services; and the informed consent process for prospective living donors in adherence with applicable OPTN policy. The plan shall include the feasibility of using focus groups or other human center design techniques to ensure that the content of the web page is responsive to concerns/common questions of living donors and potential living donors.

Upon approval of the plan by the COR, the Contractor shall implement the plan.

Task 8 SRTR Data Management

8.1 Create SRTR Standard Analysis Files (SAF) and develop an operations manual to document the work processes in generating SAFs

Create Standard Analysis Files (SAFs) that incorporate data collected by the OPTN Contractor as well as calculated analytical variables and data from external data sets as allowed per data use agreements.

Develop a SAF operations manual to document the work processes used into creating and updating SAFs.

Develop an electronic data dictionary to describe the source, format and definition of the data elements contained in the SAFs.

8.2 Create Living Donor Registry Data File

Create a SRTR living donor registry data file that incorporates data collected by the Contractor as well as information from other data sets included in the SRTR living donor registry.

Develop a report documenting the work processes used in creating and updating the living donor registry data file.

Develop an electronic data dictionary to describe the source, format and definition of the data elements contained in the living donor registry data file.

8.3 Monthly data quality report to the OPTN Contractor

Implement procedures to evaluate the quality of official OPTN data provided by the OPTN Contractor.

Provide a monthly data quality report to the OPTN Contractor and the COR.

Include a summary of data quality issues in the quarterly progress report provided to the COR.

8.4 Identify data sources outside of the OPTN for incorporation into the SRTR database in order to validate and enhance data collected by the OPTN.

Identify available external data sources to address research questions important to organ donation, procurement, and transplantation, identified by HRSA and/or the OPTN, requiring data beyond those collected by official OPTN data collection.

Identify the needs for such data, necessary Data Use Agreements, and costs to procure such data.

Document its consideration and use of external data sources in an annual data report to the COR.

Include in the annual data report to the COR recommendations for acquisition of specific data, documenting the need and value for the acquisition. COR approval is required.

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.

8.4.1 CMS Data Agreement

Obtain Centers for Medicare & Medicaid Services (CMS) data and link these to the data obtained from the OPTN Contractor, primarily to supplement official OPTN data with information on end-stage renal disease (ESRD) patients.

Submit a Data Use Agreement to CMS to obtain Medicare data under Memorandum of Agreement between HRSA and CMS (HSB1100401/CMS IA 11-39). To obtain a copy contact sdunne@hrsa.gov.

8.5 Support existing data linkages with disease-specific registries and identify new potential linkages to disease-specific registries.

8.5.1 Update data linkages for National Cancer Institute’s Transplant Cancer Match Study

Continue to update the linkages or prepare finder files for the National Cancer Institute’s Transplant Cancer Match Study https://transplantmatch.cancer.gov/. The purpose of the Transplant Cancer Match Study is to examine cancer risk in solid organ transplant recipients. The study is a close collaboration among researchers and staff at various federal and state government agencies, including:

The National Cancer Institute;

The Health Resources and Services Administration, which oversees solid organ transplantation in the U.S.;

The Scientific Registry of Transplant Recipients (SRTR);

Multiple state and regional cancer registries throughout the U.S.

8.5.2 Identify new potential linkages to disease-specific registries

The Contractor shall identify new potential linkages to disease-specific registries and provide an annual update to the COR of registries that could benefit from SRTR data linkages.

8.6 Implement a process to archive historical datasets and programming codes for long-term retention during performance of the contract

Implement a process to maintain historical datasets and programming codes that are important to retain for future references. The process covers all major analytical tasks performed under the contract, including frequency and location of the archives.

Ensure these stored archives can be easily located and retrieved.

Submit a document describing the process within 90 days after the EDOC.

Task 9 Access to the SRTR data

9.1 Make SAF, Living Donor Registry Data, SAMs data, and all data eligible for release per 121.11 of the final rule available to the scientific community for research.

https://transplantmatch.cancer.gov/

According to final rule section 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 . . . Scientific Registry’s resources permit, or as directed by the Secretary.” 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. As contemplated by the final rule, the contractor may charge researchers for the cost of data file production.

In addition, the Contractor shall ensure that:

all requests be processed expeditiously, with data normally made available within 30 days from the date of request; and an estimate of charges shall be provided to the requester before processing the request.

Provide technical assistance in utilization of the data.

Require the researchers to complete the Data Use Agreement approved by HRSA for both OPTN and SRTR Contractors.

Submit requests for data with Personally Identifiable Information (PII) to the COR for review and approval.

Track the number of data file requests and report this information in the quarterly progress report.

9.2 Respond to data requests from within the U.S. Department of Health and Human Services

(HHS) within a specified schedule.

Make available to the COR data reports based on format and media specifications (e.g., paper, electronic, spreadsheet, etc.) provided by the COR.

Provide data reports (through the COR) to components within HHS. 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 subject to 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 federal 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).

Notify the COR within three (3) days of the request if: (1) the data are not collected and/or verified; (2) release of the data violates applicable laws or the SORN; or (3) the data and information may be exempt from disclosure under the FOIA.

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

9.3 The Contractor shall respond to data requests from outside the U.S. Department of Health and

Human Services (HHS) within established timeline

Respond to routine data requests within 30 days of receipt and to more complex requests (i.e., requests that take more time to complete) within 60 days of receipt. If it takes 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-HHS entities to cover the reasonable costs of providing data or data analyses.

Track the number of routine and complex data requests from outside the Government and report this information in the quarterly progress report.

utilize limited license agreements, when applicable or required by HRSA.Limited License agreements must stipulate that failure to comply with the terms of may result in no further data disclosures.

Task 10 Simulated Allocation Models (SAMs)

The SRTR SAMs are a critical supporting component of the OPTN policy-making process. The purpose of simulation allocation modeling is to estimate the potential effects of a change in OPTN policy on outcomes experienced by waitlist candidates and transplant recipients. The updated and modernized

SAMs produced under the prior SRTR contract include the: Liver Simulated Allocation Model (LSAM);

Thoracic Simulated Allocation Model (TSAM) for heart and lung; and Kidney/Pancreas Simulated Allocation model (KPSAM).

10.1 Maintain SAMs to support the analytical needs of the OPTN.

Maintain and update the modernized SAMs produced under the prior SRTR contract to support the analytical needs of the OPTN.

Revise input files, allocation rules, and any other SAMs components following implemented changes in OPTN allocation policies, acceptance criteria, or other variables.

Submit updated SAMs with current input files and allocation rules to the COR within three months after implementation of any OPTN allocation policy or other relevant changes.

10.2 Make updated and modernized SAMs software available to the public through an open source distribution mechanism.

The government wishes to maximize transparency in the OPTN policy-making process supported by the SAMs and increase options for future innovative contributions to OPTN policy-making. As such, the

Contractor shall:

Make available to the public all SAMs software through open source licensing and distribution.

Contractor support of open source SAMs software will allow researchers and other interested members of the public to contribute to the process of identifying meaningful changes in OPTN allocation policies.

Work with the COR to develop, manage, and maintain an open source licensing and distribution plan for the SAMs. The plan shall: determine the terms and conditions of open source licensure and distribution; determine the place of open source access; identify appropriate websites to store, manage, and track code changes; identify a process for a) responding to technical questions regarding use of the SAMs software and (b) evaluate contributions from the public to the software.

Submit a revised plan, if necessary, within 60 days of the start of each option period to the COR for review and approval.

Implement the plan, once approved by the COR. Maintain technical guidance materials necessary and sufficient to support public use of open source SAMs software.

Maintain and include in the open source software up-to-date process descriptions of current OPTN allocation policy included in the SAMs in the form of flowcharts or prose descriptions designed to educate users about OPTN allocation policy.

10.3 Offer SAMs technical assistance upon request

provide to requestors up to 2 hours of technical assistance on the SAMs without charge.

include as part of the open source software, instructions for requesting technical assistance.

If the assistance requested requires more than 2 hours, fees may be charged to cover the reasonable costs of providing assistance. The Contractor shall notify the COR by email of such requests.

Task 11 Transplant and organ procurement system performance improvement

11.1 The Contractor shall maintain and improve its portfolio of performance improvement tools for transplant programs and OPOs.

Maintain a portfolio of tools to improve system performance and assist transplant centers and OPOs in self-monitoring of their performance.

Develop a plan for approval by the COR identifying improvements and additions to the portfolio of tools to be provided to transplant centers and OPOs. The plan shall include a timeframe for provision of tools and an evaluation mechanism and a process for annual review and reporting to ensure that tools are effective and being used appropriately.

Tools may include: data review tools, performance calculators, and Cumulative Sum (CUSUM) charts to assist transplant programs and OPOs in monitoring performance.

11.2 The Contractor shall provide technical assistance to OPOs and transplant programs using

SRTR tools for quality improvement provide upon request to each OPO or transplant programs, a standard amount of technical assistance, not to exceed one full business day annually.

provide on the SRTR website instructions for requesting customized technical assistance notify the requestor of the amount of time required to provide the requested assistance

If the assistance requested requires more than the standard time allotted, fees may be charged to cover the reasonable costs of providing assistance. Cost information for additional technical assistance shall be posted on the SRTR website. The Contractor shall notify the COR by email of such requests.

Task 12 Publications

12.1 Develop OPTN/SRTR Annual Data Report (ADR) for public posting.

Collaborate with OPTN Contractor to develop an OPTN/SRTR ADR, publishing data on organ donation and transplantation, containing longitudinal analyses that describe trends over time on organ donation and transplantation, showing both recent activity and 10- year trends.

Work with the COR to develop a time line after contract award.

Provide a draft copy of ADR to OPTN Contractor and COR for review and comments.

Incorporate the comments from both OPTN contractor and the COR before submit a final copy of ADR for review by HRSA. HRSA will review the editorial style, and appearance of the ADR.

The ADR shall be posted on http://srtr.transplant.hrsa.gov and meet section 508 compliance requirements. There will be no print copy of the Annual Data Report.

12.2 Assist in Preparing Biennial Reports to Congress.

NOTA (42 U.S.C. 274d) requires the Secretary to submit a Biennial Report to Congress on the Scientific and Clinical Status of Organ Transplantation (Report to Congress) including analysis of information derived from the Scientific Registry of Transplant Recipients. The Contractor shall assist the COR by providing data and other content for the report as requested and in the format required by HRSA, by the COR-specified deadlines. The COR shall inform the Contractor the dates that the reports will be submitted for HRSA/HHS clearance.

12.3 Prepare abstracts for presentation and conferences and manuscripts for publication in peer-reviewed scientific journals based on the analysis conducted under the contract.

Prepare abstracts for submission to major conferences in the fields of organ transplantation.

Submit manuscripts based on analyses conducted for the OPTN or HRSA, such as analyses on organ allocation policies, waitlist and transplant outcomes, organ donation, and OPO and transplant program performance assessment.

Submit abstracts and manuscripts to the COR for review at least 20 business days prior to submitting manuscripts for publication or abstracts to conference organizers.

Task 13 Maintain a National Living Donor Registry http://srtr.transplant.hrsa.gov/

Establish a living organ donor registry to collect information on the long term physical health, psychosocial well-being, and other outcomes related to the act of living donation. Critical to this effort is data collection on all potential living donors evaluated at transplant programs. Adequate information on outcomes that are important to donors may take many years to develop and may only be evident by comparing large numbers of donors with suitable controls. Thus, there is a need to establish a national living donor registry, and to prospectively follow an equally healthy group of individuals whose outcomes can be compared with those of donors over their lifetimes.

Collect baseline data of willing individuals who are evaluated at transplant programs as potential living donors. .

Match this baseline data with data available from external data sets and potential surveys to create a record of the individual’s physical and psychosocial well-being. Data will be collected from individuals who proceed with living donation, as well as those who are approved to be living donors but do not proceed with the donation. Data on the latter group are collected to serve as a control group.

13.1 Living Donor Registry

Maintain and expand the living donor registry known as the Living Donor Collective (LDC), established as a pilot program under the SRTR Contract in effect from 9/2015 to 9/2020. This registry contains information on living organ donor candidates who are evaluated by transplant programs that have become members of the LDC. Provide quarterly status reports to the COR describing recent activity pertaining to the registry and a high-level summary of data collected that quarter. The report shall also contain updates on efforts to promote and publicize the LDR and information on living donor updates to the website.

13.2 Develop surveys and collect data

Maintain data collection efforts in place during the prior SRTR contract.

Report each contract period on potential expanded data collection efforts recommended to improve the assessment of living donor outcomes. Following COR approval, the Contractor shall implement data collection expansions.

Develop any necessary Office of Management and Budget (OMB) information collection request clearance materials to comply with the Paperwork Reduction Act (PRA).

Prepare and submit 60-day and 30-day Federal Register Notices as appropriate and an information collection request clearance package in accordance with OMB's clearance process.

The COR will provide applicable forms to the Contractor needed to draft the FRNs and draft the package for OMB clearance.

The Contractor shall submit a draft 60-day FRN, a draft 30-day FRN and draft clearance package to the COR.

The COR will review and the Contractor shall revise the documents accordingly.

The COR will submit the draft documents to the HRSA Information Collections Clearance Officer for review/approval. Based on this review, the Contractor shall make necessary changes to these documents as requested by the COR.

Once the package has been submitted to OMB for review/approval, the Contractor shall provide, in writing and within one week, a draft response to HRSA on the OMB Desk Officer’s questions and make any required revisions.

Develop a plan to link baseline data collected from participating living donor programs with data on individuals from national data sets. Data sets could include, but are not limited to the

National Death Index (NDI) database, pharmacy claims databases, and other insurance and beneficiary data bases that may provide insight into general clinical condition of individuals being followed in the registry.

Include requests for data purchases to supplement the living donor registry in the annual external data set request provided to the COR.

13.3 Recruitment of and T.A. for living donor transplant programs

Develop a plan to (1) recruit new living donor transplant programs that perform living donor kidney and liver transplants and (2) provide technical assistance pertaining to obtaining Institutional Review Board approvals and any other local approvals that may be needed.

The plan shall include:

details for a phased-in approach to eventually include participation by all transplant centers performing living donations in the LDC (see also Task 13.6, below) resources to be allocated to support program coordinator time to conduct baseline data collection.

(see also Task 13.6, below)

13.4 Maintain a living donor registry data collection portal

Maintain and enhance the data collection portal established during the prior SRTR contract.

Provide annual plans to the COR for enhancing the data portal.

Implement the data portal enhancement plan after COR approval.

13.5 Facilitate living donor registry meetings

Convene quarterly calls of participating transplant programs.

Present a range of topics during quarterly meetings, including but not limited to: living donor and family education and support resources; best practices for ascertaining information needed by potential living donors and their families; and development of center-specific performance comparisons for patients.

13.6 Plan for Living Donor Registry expansion

The key to a viable living donor registry is participation of all living donor transplant centers…