Attachment_H_-_QASP.doc

Attachment H Quality Assurance Surveillance Plan (QASP)

Scientific Registry of Transplant Recipients (SRTR)

5/26/2015 Version 1.0

31 Vision

1.1 Mission

3 Purpose 4 Authority 5 Roles and Responsibilities

5.1 Program / Project Manager

5.2 Contracting Office

5.3 Contracting Officer's Representative (COR)

6 Performance Requirements and Method of Surveillance

6.1 Contract Surveillance

6.2 Surveillance Matrix

Appendix 1 - Surveillance Matrix

Quality Assurance Surveillance Plan (QASP) Scientific Registry of Transplant Recipients (SRTR)

1 Vision

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.

1.1 Mission

The Division of Transplantation (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 Organ Procurement and Transplantation Network (OPTN), to allocate and distribute donor organs to individuals waiting for an organ transplant. The allocation of organs is guided by organ allocation policies developed by the OPTN with analytic support provided by the Scientific Registry of Transplant Recipients (SRTR).

3 Purpose

This Quality Assurance Surveillance Plan (QASP) is a government-developed document used to determine if the contractor's performance meets the performance standards contained in the contract. The QASP establishes procedures on how this assessment/inspection process will be conducted. It provides the detailed process for a continuous oversight process:

· What will be monitored

· How monitoring will take place

· Who will be conduct the monitoring

· How monitoring efforts and results will be documented

The contractor is responsible for implementing and delivering performance that meets contract standards using its Quality Control Plan. The QASP provides the structure for the government's surveillance of the contractor's performance to assure that it meets contract standards. It is the government's responsibility to be objective, fair and consistent in evaluating contractor performance.

The QASP is not part of the contract nor is it intended to duplicate the contractor's quality control plan. This QASP is a living document. Flexibility in the QASP is required to allow for an increase or decrease in the level of surveillance necessary based on contractor performance.

The government may provide a copy of the QASP to the contractor to facilitate open communication. In addition, the QASP should recognize that unforeseen or uncontrollable circumstances might occur that are outside the control of the contractor.

Bottom line, the QASP should ensure early identification and resolution of performance issues to minimize impact on mission performance.

4 Authority

Authority for issuance of this QASP is provided under Part 46 of the Federal Acquisition Regulation, Inspection of Services clauses, which provides for inspection, acceptance and documentation of the service called for in the contract or order. This acceptance is to be executed by the contracting officer or a duly authorized representative.

5 Roles and Responsibilities

The following personnel shall oversee and coordinate surveillance activities.

5.1 Program / Project Manager

The PM provides primary program oversight, nominates the COR, ensures the COR is trained before performing any COR duties and supports the COR's performance assessment activities. While the PM may serve as a direct conduit to provide Government guidance and feedback to the Contractor on technical matters, they are not empowered to make any contractual commitments or any contract changes on the government's behalf.

Assigned PM: Mesmin Germain

Organization or Agency: HHS/HRSA/HSB/DoT

Telephone: (301)443-0053

Email: mgermain@hrsa.gov

5.2 Contracting Office

The contract specialist shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The contract specialist shall also ensure that the contractor receives impartial, fair, and equitable treatment under this contract. Determine and document the final assessment of the contractor's performance in the governments past performance tracking system.

Assigned Contract Specialist: Veronica Dhaness

Organization or Agency: HHS/HRSA/OAFM

Telephone: (301)443-5131

Email: Vdhaness@hrsa.gov

5.3 Contracting Officer's Representative (COR)

The COR is responsible for providing continuous technical oversight of the contractor's performance. The COR uses the QASP to conduct the oversight/surveillance process. The COR shall keep a Quality Assurance file that accurately documents the contractor's actual performance. The purpose is to ensure that the contractor meets the performance standards contained in the contract. The COR is responsible for reporting early identification of performance problems to the contract specialist. The COR is required to provide an annual performance assessment to the contract specialist which will be used in documenting past performance. The QASP is the primary tool for documenting contractor performance. The COR is not empowered to make any contractual commitments or to authorize any contractual change on the Government's behalf.

Assigned Contracting Officer's Representative: Monica Lin

Organization or Agency: HHS/HRSA/HSB/DoT

Telephone: (301)443-2776

Email: mlin@hrsa.gov

6 Performance Requirements and Method of Surveillance

This section describes the special requirements for this effort. The following sub-sections provide details of various considerations on this effort.

6.1 Contract Surveillance

The goal of the QASP is to ensure that contractor's performance is effectively monitored and documented. The COR's contribution is their professional, non-adversarial relationships with the contract specialist, PM and the contractor, which enables positive, open and timely communications. The foundation of this relationship is built upon objective, fair, and consistent COR evaluations of contractor performance against contract requirements. The COR uses the methods contained in this QASP to ensure the contractor is in compliance with contract requirements. The COR function is responsible for a wide range of surveillance requirements that effectively measure and evaluate the contractor's performance. The COR shall inform the Contractor when the task performance does not meet the performance standard. Additionally, this QASP is based on the premise that the contractor, not the government, is responsible for management and QC/QA actions to successfully meet the terms of the contract.

6.2 Surveillance Matrix

The Surveillance Matrix (Attachment 1) is the list of performance objectives and standards that must be performed by the contractor. This matrix details the method of surveillance the COR will use to validate and inspect these performance elements. Inspection of each element will be documented in the COR file.

Performance objectives define the desired outcomes. Performance Standards define the level of service required under the contract to successfully meet the performance objective. The inspection methodology defines how, when, and what will be assessed in measuring performance. The Government performs surveillance, using this QASP, to determine the quality of the contractor's performance as it relates to the performance element standards. The PRS should be used to form the foundation of the COR's inspection checklist.

In evaluating the quality of contractor’s performance, the following performance ratings may be used.

Performance

Rating Criteria

Appendix 1 - Surveillance Matrix

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).

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

a) 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) The updated transition plan is submitted within 21 days after the EDOC.

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

What: Transition Plan

How: Review the transition plan against the standards

Frequency: Once Who: COR

Standard(s): a, b

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

Deliverables:

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

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

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

What: Formal written agreement for data transfer

How: Review the Formal written agreement against the standards.

Frequency: Once Who: COR and Office of the General Counsel

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.

Deliverables:

D06 Strategic plan

a) 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) Strategic plan is provided to the Steering Committee for review during annual meeting.

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

What: Strategic plan

How: Review the plan against the standards Frequency: Once a year

Standard(s): a, b, c

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

Deliverables:

D07 Project conference call agenda D08 Minutes of project conference call

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

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

What: Meeting agendas, minutes, and contractor's participation in conference calls

How: Monitor timeliness of submission

Frequency: Twice per month

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

Deliverables:

D09 Joint SRTR and OPTN CORs and contractors meeting agenda items

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

What: Meeting agenda items

How: Review meeting agenda item submission for relevance and timeliness

Frequency: Twice a year

Standard(s): a

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

Deliverables:

D10 Quarterly written progress reports

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

b) 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

What: Quarterly written progress reports How: Review the report against the standards Frequency: Quarterly

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.

Deliverables:

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

a) Contractor submits written request within 7 days of receiving request.

What: Written request for participation in meeting or presentation as SRTR representative

How: Review the request and have follow-up discussion with the contractor if necessary.

Frequency: As required

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

Deliverables:

D12 In-person briefing to the COR and other appropriate Government staff.

D13 Briefing materials including recommendations

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

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

What: Briefing materials

How: Review the briefing materials against the standards Frequency: Once

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

Deliverables:

D14 OPTN committee analytical support plan

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

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

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

What: Analytical support plan

How: Review the analytical support plan against the standards Frequency: Yearly and as updated

Standard(s): a, b, c, d

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

Deliverables:

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

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

b) 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) The Contractor assigned staff will attend DAC in person meetings twice a year.

What: List of nominees for DAC membership

How: Review the list against the standards Frequency: As requested

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

Deliverables:

D14 OPTN committee analytical support plan

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

3.3 Establish and Maintain SRTR Specific Committees

3.3.1 The Contractor shall establish and maintain a steering committee.

Deliverables:

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

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

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

What: Documentation of steering committee structure and roles and responsibilities and membership

How: Review the document against the standards Frequency: Once and as updated

3.3.1.1 The Contractor shall facilitate meetings of the Steering Committee.

Deliverables:

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

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

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

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

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

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

What: Meeting schedule, materials and minutes

How: Review materials and monitor meeting schedule against the standards Frequency: Once a year

Standard(s): a, b, c, d, e

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.

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

a) Charter previously developed is reviewed and modified.

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

c) 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) The statement of purpose demonstrates the need to constitute subcommittee and working group.

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

What: List of Visiting Committee members

How: Review against the standards Frequency: Yearly and as updated

Who: COR

Standard(s): b, c

What: Statement of purpose and proposed membership How: Review against the standards Frequency: As required

Standard(s): d, e

3.3.2.1 The Contractor shall facilitate meetings of the Visiting Committee.

Deliverables:

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

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

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

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

What: Meeting packet and minutes

How: Monitor meeting schedule and materials submission against the standards Frequency: Four times a year

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

Deliverables:

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

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

What: Documentation of procedures to address conflict of interest

Frequency: Once and as updated

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.

Deliverables:

D28 Documentations requested by HRSA OIT D29 Security Authorization package

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

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

c) 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)

What: IT Security and privacy Documentation How: Review security documents and inspect contractor's system Frequency: Continuous

Who: COR, OIT

Standard(s): b

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

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

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.

What: Secure website management procedure documentation How: Review document against the standards Frequency: Once and as updated Who: COR

Standard(s): a

What: Websites improvement and enhancement project plan

How: Review the plan against the standards Frequency: Once and as updated

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.

Deliverables:

D32 SAF operations manual D33 Quarterly SAF

a) The Contractor submits SAF operation manual within 180 days after the EDOC.

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

What: Operations manual

Frequency: Once and as updated

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

Deliverables:

D34 Monthly Data Quality Report to the OPTN Contractor

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

What: Data quality report

Frequency: Monthly Who: COR, OPTN COR

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.

Deliverables:

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

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

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

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

Deliverables:

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

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

What: Cancer registry linkages How: Monitor the responses to cancer registries Frequency: As requested Who: COR, NCI PI

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.

Deliverables:

D38 Document describing archiving process D39 Status updates of archived materials

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

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

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

What: Review the archive process document How: Review the document against the standards and timeliness of submission Frequency: Once and as updated

3.6 Access to the SRTR data

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

Deliverables:

D10 Quarterly written progress reports D40 Data requests requiring release of PII

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

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

What: SRTR website

How: Monitor posting of the instructions against the standards Frequency: Once and as updated Who: COR

Standard(s): a

What: SAF requests How: Monitor processing of SAF requests against the standards Frequency: As requested

Standard(s): b, c

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

Deliverables:

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

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

What: Response to data requests

How: Monitor completion of requests against the standards Frequency: As requested

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

Deliverables:

D10 Quarterly written progress reports

a) 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) 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.

What: Response to data requests How: Monitor completion of requests against the standards Frequency: As requested Who: COR

Standard(s): a

What: SRTR website

How: Monitor posting of the instructions against the standards Frequency: Once and as updated

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.

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

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.

What: Analysis plan, report and presentation How: Review the plan and report against the standards and monitor timeliness of submission Frequency: As requested

3.7.2 The Contractor shall provide analytic support to HRSA.

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

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.

What: Analysis plan, report and presentation How: Review the plan and report against the standards and monitor timeliness of submission Frequency: As requested

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

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

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.

What: Analysis plan and report

Frequency: Once

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

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

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.

What: Analysis plan and report

Frequency: Once

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.

Deliverables:

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

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

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

What: Schedule for updating SAMs How: Review the plan against the standards and monitor timeliness of submission Frequency: Once and as updated

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

Deliverables:

D55 Updated SAMs D56 Plan for enhancement of the SAMs

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

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

c) Enhancement is completed within specified schedule.

What: plan for enhancement of the SAMs

How: Review the plan against the standards and monitor timeliness of submission Frequency: Once and as updated

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

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.

What: SRTR website

How: Monitor posting of the instructions against the standards Frequency: Once and as updated Who: COR

Standard(s): a

What: Response to SAM requests How: Monitor completion of requests against the standards

Frequency: As requested

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).

Deliverables:

D57 Draft PSRs for COR review D58 Post transplant program and OPO-specific information on the SRTR public website (http://www.srtr.org/csr/current/Centers/Default.aspx)

a) 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 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).

b) The publication schedule and cohorts contained in the next PSR cycle are published on the web site within 30 days after the public posting of each PSR.

c) Contractor submits draft PSR for COR review 14 days prior to public posting on web site.

d) The PSRs will be published as scheduled every six months.

e) Program performance information is presented at varying level of complexity appropriate for groups (including patients, physicians and general public) with different level of needs.

f) The technical documentation including methods and models are published on the website.

g) Major changes to the PSRs are announced on the website.

h) National center-level summary data are available for download on the SRTR public website.

What: Draft PSRs

How: Review the reports against the standards and monitor timeliness of publication Frequency: Every 6 months Who: COR

Standard(s): a, b, c, d, e

What: SRTR website

How: Monitor posting of the technical information against the standards Frequency: Once and as updated

Standard(s): f, g, h

3.9.2 The Contractor shall develop a manual that documents the process of developing risk-adjusted models used in the PSRs.

Deliverables:

D59 Manual for developing risk-adjusted models used in the PSRs

a) The manual describes the schedule to update the models, and the methods used to select the variables and handle the missingness of variables.

b) The manual describes process of soliciting inputs from organ-specific experts in the development of models.

c) The manual describes the assessment of the performance of the predictive models include reporting of discrimination and calibration.

d) The manual is submitted within 180 days after the EDOC.

What: Manual for development of risk-adjusted models.

How: Review the manual against the standards Frequency: Once and as updated

3.9.3 The Contractor shall develop and implement a plan to provide technical assistance to OPOs and transplant programs in understanding program-specific data for quality improvement.

Deliverables:

D60 Plan for providing technical assistance D61 Notification of requests for customized technical assistance

a) Technical assistance plan is submitted within 120 days after the EDOC.

b) STD: Technical assistance approach is cost effective and ensure assistance is accessible to all programs.

c) STD: Instructions to request customized technical assistance and cost information for technical assistance are posted on the SRTR public website within 120 days after the EDOC.

What: Technical assistance plan

Frequency: Once and as updated Who: COR

3.9.4 The Contractor shall continue to develop and provide tools for performance improvement by transplant programs and OPOs.

Deliverables:

D62 Posting data review tools on SRTR secure website D63 Posting expected survival worksheets on SRTR secure website D64 Posting CUSUM charts on SRTR secure website D65 CUSUM Charts for additional metrics

a) STD: Data review tools are made available according to the reporting schedule posted by the Contractor. These tools are available in the secure web site for program access only,

b) STD: Expected survival worksheets are made available according to the reporting schedule posted by the Contractor. These worksheets are available in the secure web site for program access only,

c) STD: OPO yield calculator is updated every 6 months to reflect new cohort and updated coefficients.

d) STD: CUSUM charts are released monthly.

e) STD: Additional CUSUM charts are developed to monitor system performance after COR approval.

What: Data tools, worksheets How: Monitor posting of tools, worksheets against the standards Frequency: Every 6 months Who: COR

Standard(s): a, b, c

What: CUSUM Charts

How: Monitor posting of CUSUM charts against the standards Frequency: Monthly

Standard(s): d

3.10 Publications

3.10.1 The Contractor shall develop OPTN/SRTR Annual Data Report (ADR) for public posting.

Deliverables:

D66 Draft ADR D67 Final ADR

a) ADR includes tables and graphs, and maps to enhance understanding of geographic patterns and variations across the country. Short narratives accompany the tables, graphs and maps to highlight the important findings.

b) ADR meets section 508 compliance requirements.

What: ADR How: Review ADR against the standards and monitor timeliness of submission Frequency: Once a year

3.10.2 The Contractor shall prepare Biennial Reports to Congress.

Deliverables D68 Draft Biennial Report to Congress D69 Final Biennial Report to Congress

a) STD: Reports are prepared in accordance with HRSA Reports to Congress Development Guidance Document.

b) STD: Draft and final reports are submitted on schedule as specified by the COR.

What: Biennial Report to Congress How: Review ADR against the standards and monitor timeliness of submission Frequency: Every two years

3.10.3 The Contractor shall prepare abstracts for presentation and conferences and manuscripts for publication in peer-reviewed scientific journals based on the analysis conducted under the contract.

D70 Draft abstracts and/or manuscripts D71 Post published journal articles on SRTR web site

How: Review abstracts to ensure work based on the analyses done under the contract Frequency: Once a year

3.11 Optional Tasks

3.11.1 The Contractor shall establish a living organ donor registry based on the findings from the feasibility analysis (Task 3.7.3).

3.11.2 The Contractor shall submit a transition-out plan for transfer of all materials and meeting with the new Contractor during transition.

Deliverables:

D72 Plan for transitioning SRTR contract to subsequent Contractor

a) Transition plan is sent 90 days prior to the close of the contract or the 90 days before the end of the last option year exercised by the Government.

b) Plan includes a list of all materials to be transferred to the subsequent Contractor.

c) Plan includes a two-day meeting with the subsequent Contractor staff.

What: Transition-out plan

Frequency: Once