ATTACHMENT_A.Statement_of_Work.docx

ATTACHMENT A - STATEMENT OF WORK

Sickle Cell Disease Treatment Demonstration Program National Coordinating Center STATEMENT OF WORK – 7/30/2014

A. BACKGROUND

In 2004 Congress enacted and the President signed into law P.L. 108-357, the American Jobs Creation Act of 2004. Section 712 of P.L. 108-357 authorized the Sickle Cell Disease Treatment Demonstration Program (SCDTDP) under the Health Resources and Services Administration (HRSA). The legislation requires the demonstration program to be carried out through two mechanisms: a grant program and a contract.

Sickle cell disease is an inherited red blood cell condition. In affected individuals, the abnormal red blood cells break easily and clog blood vessels to block blood flow to organs and tissues. This process results in anemia, periodic pain episodes (at times severe), and ultimately can damage tissues and vital organs and lead to increased infections and early death. In the United States, most cases of sickle cell disease occur among people of African ancestry (one in 400 African American births) but those of Mediterranean, Middle Eastern, or Indian background or from countries to which people from these regions have migrated are also affected. It is estimated that more than two million Americans are carriers of heterozygote for sickle cell disease and over 70,000 have the disorder. Annually approximately 1,000 newborns are identified with sickle cell disease through state newborn screening programs.

Early diagnosis of sickle cell disease is critical so that children who have the disorder can receive proper interventions. Newborn screening for sickle cell disease followed by parental health education, enrollment in comprehensive care, initiation of penicillin prophylaxis and anti-pneumococcal vaccination within the first two months of life can prevent death from severe infections.

Access to care for individuals with sickle cell disease is uneven. Comprehensive care for children with sickle cell disease is generally more available than for adults because there are relatively fewer clinicians with expertise and willingness to care for adults with sickle cell disease. Even for children, geographic, economic, and cultural barriers may prevent them from accessing the care required to prevent morbidity and mortality. Further, while there have been advances and new developments in sickle cell disease treatment such as hydroxyurea to increase fetal hemoglobin resulting in increased survival and decreased morbidity, access to therapies have not necessarily been easy for many patients. A survey of sickle cell disease treatment center directors and associates suggested that adoption of new developments in treatment lag in the community, and this could be attributed primarily to physicians’ lack of knowledge.

To address these barriers to access to sickle cell disease care, the Maternal and Child Health Bureau (MCHB) is adjusting the SCDTDP to a regional model. The regional approach has been used by MCHB with other programs and will increase the reach of the program to provide access to a greater number of patients. The goal of the program is to increase the number of providers treating patients with sickle cell disease, increase the number of providers prescribing disease modifying therapies, such as hydroxyurea, and increase the number of sickle cell patients receiving care from providers knowledgeable about sickle cell disease.

B. SCOPE

The SCDTDP was created by the enactment of P.L. 108-357, the American Jobs Creation Act of 2004. Section 712 of P.L. 108-357 authorized a demonstration program. The SCDTDP supports the development and establishment of systemic mechanisms to improve the prevention and treatment of Sickle Cell Disease and its complications, including the coordination of service delivery for individuals with Sickle Cell Disease. The legislation requires that HRSA develop a contract to gather data on service delivery to the sickle cell population, propose a model protocol, and submit a Report to Congress on the program at the end of the contract period.

C. PURPOSE

The purpose of this procurement is to obtain services to gather data from and evaluate the performance of the SCDTDP grantees in addressing the three goals of the program, including: 1) increasing the number of providers treating persons for sickle cell disease for sickle cell related issues; 2) increasing the number of providers prescribing disease modifying therapies such as hydroxyurea; and 3) increasing the number of sickle cell patients that are receiving regular care with providers knowledgeable about treating sickle cell disease.

The contractor will be responsible for supporting data collection and reporting results of the SCDTDP as follows:

· Provide project management and administrative support that allows HRSA to control costs and advances the activities of the SCDTDP

· Assist HRSA in creating and providing support to the Oversight Steering Committee of the SCDTDP

· Create a database with data elements and a data dictionary that allows HRSA to collect and evaluate data from multiple regions on meeting the goals of the program

· Create a model protocol and strategies for improving sickle cell care from information gathered from the database, the SCDTDP grantees, the OSC, and HRSA partners to improve sickle cell care

· Create a web-based Compendium of Tools and Materials created by activities of the SCDTDP that can be accessed and utilized by other sickle cell stakeholders

· Create and implement reporting strategies that allow HRSA to report results of the program to the general public

· Create a Report to Congress on the SCDTDP

D. TASKS

The contractor shall complete the following tasks:

Base Year Task 1: Project Management and Administration Task 1.1 Within 7 days of the effective date of the contract (EDOC), the contractor shall arrange for the Project Director and key contract staff to meet with the COR and key HRSA staff for a Kickoff Meeting. The Kickoff Meeting shall take place at the Parklawn Building in Rockville, Maryland. The contractor shall discuss with HRSA staff:

· The legislation and its specific requirements

· The components necessary for planning and execution of the contract

· Proposed timeline for the completion of each of the contract components

· Elements of the timeline, requirements of progress quarterly reports, the Report to Congress, final reports and Executive summary

· Roles of the COR, Project Director and contractor

· Selection and role of the Chair for the Oversight Steering Committee (OSC) and OSC members

The contractor shall keep minutes of the Kickoff Meeting and provide an electronic copy to the COR within 3 days after the Kickoff Meeting.

Task 1.2 The contractor shall develop, implement, and maintain a reporting and forecasting system detailing monthly spending, spending to date (including both direct and indirect costs), and funds remaining. This information shall be reported to the COR by the 15th of each month, and shall be readily available at other times upon request.

Task 1.3 The contractor shall submit a revised timeline to the COR, which includes the list of tasks with all sub-tasks, a list of contractor staff that are responsible for each task, and estimated completion date of each task. The timeline shall be updated regularly by the contractor and used to evaluate progress toward completion of activities in the contract. Monthly meetings between contractor and COR shall include review of progress to date on all tasks listed in the timeline. The timeline shall be submitted one (1) month after EDOC.

Task 1.4 The contractor shall maintain a regular contact schedule with the COR, including a monthly meeting with the COR, and a quarterly meeting with the COR, the Director of the Division of Services for Children with Special Healthcare Needs, and other key staff members of MCHB. The quarterly meeting shall be conducted by conference call. The contractor shall submit a brief meeting summary with action items within one (1) week after each conference call.

Task 1.5 The contractor shall ensure that all travel to perform work under this contract is in accordance with the Federal Travel Regulation. The contractor shall obtain approval from the COR in advance of travel. When an in-person meeting or conference is planned, the contractor shall be responsible for developing and submitting a budget for the conference or meeting in advance to allow approval by the COR.

Task 1.6 Within fourteen (14) days of EDOC, the contractor shall meet with HRSA IT Security to discuss HHSAR security requirements.

Task 2: Sickle Cell Disease Treatment Demonstration Program Oversight Steering Committee Task 2.1 The contractor shall submit a list of proposed members (not to exceed 15) of the Oversight Steering Committee (OSC) for review and approval by the COR. The list shall be submitted in matrix format indicating the following information: discipline, degree(s), the organizations represented or expertise of the proposed members, and prior experience on federal working groups. The contractor shall propose the Chair of the OSC for review and approval by the COR. The contractor shall work with MCHB to recruit members and to coordinate and facilitate meetings of the OSC. The OSC shall continue to operate in accordance with the structure and rules established in the base period through the option periods. The contractor shall have a maximum of four (4) virtual meetings with the OSC annually. The list of proposed Chair and members for the OSC should be submitted to the COR within one (1) month of the EDOC.

Task 2.2 The contractor shall provide letters of interest and curricula vitae for each of the proposed OSC members for review and approval, including the Chair. The contractor shall assist the COR and HRSA staff in the selection process of the OSC Chair and the OSC members. The letters of interest and curricula vitae shall be submitted to the COR within two (2) months of the EDOC.

Task 2.3 The contractor shall schedule the first teleconference of the OSC within 3 months of the effective date of the contract and provide the draft of the proposed meeting agenda two weeks prior to the meeting. At least one representative from each grant site should be on the first call of the OSC. Agenda items shall include those items outlined below:

· Review of the history of the legislation authorizing the demonstration program

· Review of the requirements specified in the authorizing legislation

· Introduction of the COR and other HRSA staff

· Role of funding agency and contractor

· Role of the Grantee Group

· Communication Plan for the Project (that includes the Grantee Group, OSC, and the COR)

· Discussion of plans for the OSC

· Discussion of timeline and individual projects contained within the timeline

· Other items determined by the contractor in consultation with the COR and the Grantee Group.

Task 2.4 The contractor shall arrange quarterly OSC meetings by conference call. The contractor shall provide the COR with agendas and planning materials one (1) week prior to each OSC conference call. The contractor shall provide a conference line for each conference call and provide written summary notes with action items from each conference call to the COR within one (1) week after the calls.

Task 3: Creation of Database and Program Evaluation

Task 3.1 The contractor shall gather and review previous reports, data, databases, data elements, questionnaires, surveys, and tools and materials regarding evaluation of the SCDTDP from prior years. The contractor shall provide the COR with a report detailing findings and recommendations on application of prior deliverables to the efforts of this contract three (3) months after EDOC.

Task 3.2 The contractor shall plan and conduct a conference including SCDTDP grantees, OSC members, HRSA partners, and other stakeholders to collect information on strategies for data collection for sickle cell disease. The conference shall be held in-person in the base year of the contract, in the Bethesda/Rockville area. The contractor shall submit an agenda and propose a method for using the conference to gather information and strategies that allow HRSA and its partners to develop data elements and database for the SCDTDP. A conference report shall include findings and recommendations for building a database and creating data elements. The Data Conference shall be held within three (3) months of EDOC. The Data Conference Summary Report with Recommendations shall be submitted to the COR one (1) month after the Data Conference.

Task 3.3 The contractor, in collaboration with SCDTDP grantees, the OSC, HRSA, and HRSA partners, shall develop and implement a database for collecting and analyzing grantee data around the three goals of the SCDTDP program: 1) increasing the number of providers treating sickle cell patients for sickle cell related issues in each region, 2) increasing the number of providers prescribing disease-modifying therapies, such as hydroxyurea, and 3) increasing the number of sickle cell patients receiving care from providers with the knowledge to treat sickle cell disease. In addition to collecting data regarding the three goals of the program, the database shall also be able to collect general information about the patient population, including demography information, geographical information, and information about services delivery. The database shall be delivered to the COR one month prior to the end of the base year of the contract.

Task 3.4 The contractor, with the SCDTDP grantees, the OSC, the COR, and HRSA partners, shall develop a data dictionary to ensure that each region is collecting consistent data regarding the goals of the SCDTDP. The Database Data Dictionary shall be submitted to the COR with the database one month prior to the end of the base year of the contract.

Task 3.5 The contractor shall revise data collection strategies in collaboration with other federal agencies and stakeholders that are currently working to improve data collection on the sickle cell population and sickle cell care, as directed by the COR. In cases where a partnership between HRSA and other stakeholders working in this space is beneficial, the contractor shall propose how a partnership would benefit the SCDTDP and shall assist the COR in developing collaborations.

Task 4: Reporting and Communication The contractor shall be responsible for the following reports and reporting strategies:

Task 4.1 Quarterly Reporting (All Contract Periods) The contractor shall submit a detailed progress report to the COR on a quarterly basis. This report shall include a complete list of all tasks and subtasks of the contract and outline progress made in the reporting period, an explanation for any delays and a revised timeline for completion of each task. Activities of the OSC and any working groups shall be outlined in the appropriate tasks.

Task 4.2 Communication Strategies for External Stakeholders (Option Year 2 and 3) The contractor shall develop and implement a communication strategy for external stakeholders that allows the dissemination of project results through multiple venues, including national list serves, peer reviewed journals, public news outlets, newsletters, and other strategies. The strategies shall include electronic and print media where cost effective.

The strategy to disseminate all tools and educational materials gathered and developed during the contract periods shall target a diverse group of stakeholders, including federal agencies, university medical centers, primary care providers, advocacy groups, and patient groups, as well as among the general population. This shall include dissemination of a compendium of sickle cell resources and best practices that were developed during the contract.

Option Year 1

Task 1: Project Management and Administration

Task 1.1 The contractor shall maintain a reporting and forecasting system detailing monthly spending, spending to date (including both direct and indirect costs), and funds remaining. This information shall be reported to the COR on a monthly basis. This report shall be submitted to the COR by the 15th of each month and shall be readily available at other times upon request.

Task 1.2 The contractor shall maintain a timeline, including the list of tasks with all sub-tasks, a list of contractor staff that are responsible for each task, and estimated completion date of each task. The timeline shall be updated regularly and used by the contractor to evaluate progress toward completion of activities in the contract. Monthly conference calls between contractor and COR shall include review of progress to date on all tasks listed in the timeline. The revised timeline shall be submitted one (1) month after EDOC.

Task 1.3 The contractor shall maintain a regular contact schedule with the COR, including a monthly meeting with the COR, and a quarterly meeting with the COR, the Director of the Division of Services for Children with Special Healthcare Needs, and other key staff members of MCHB. The quarterly meeting shall be conducted by conference call. The contractor shall submit a brief meeting summary with action items within one (1) week of each monthly and quarterly conference call.

Task 1.4 The contractor shall ensure that all travel to perform work under this contract is in accordance with the Federal Travel Regulation. The contractor shall obtain approval from the COR in advance of travel, particularly if Government rates are not attainable. When an in-person meeting or conference is planned, the contractor shall be responsible for developing and submitting a budget for the conference or meeting in advance to allow approval by the COR.

Task 2: SCDTDP Oversight Steering Committee

Task 2.1 The contractor shall arrange quarterly OSC meetings by conference calls. The contractor shall provide the COR with agendas and planning materials one (1) week prior to any OSC conference calls. The contractor shall provide a conference line for each conference call and provide written summary notes with action items from each conference call to the COR within one (1) week after the calls.

Task 3: Maintenance of Data Base and Program Evaluation

Task 3.1 The contractor shall, in collaboration with SCDTDP grantees, the OSC, the COR, and HRSA partners, maintain and modify the database to improve on the data collection strategies.

Task 4: Model Protocol and Strategy Development Task 4.1 Using data from the database, qualitative and quantitative data from SCDTDP grantees, and in collaboration with the SCDTDP grantees, the OSC, and with the COR and HRSA partners, the contractor shall identify and recommend strategies and a model protocol for achieving the three goals of the program: 1) to increase the number of providers treating sickle cell disease, 2) to increase the number of providers prescribing disease modifying therapies, such as hydroxyurea, and 3) to increase the number of sickle cell patients seeking regular care with knowledgeable providers. A report detailing the data that supports the model protocol shall be submitted to the COR one month prior to the end of Option Year 1.

Task 4.2 The contractor shall develop Technical Working Groups from members of the SCDTDP grantees to evaluate strategies for improving sickle cell care. The contractor shall coordinate and facilitate conference calls of the Technical Working Group to support the continued needs of the SCDTDP grantees.

Task 5: Compendium of Tools and Materials Task 5.1 The contractor shall work with the SCDTDP grantees to gather all tools and materials created by grantees and the OSC in support of the program. This shall include the model protocol and strategies, reports, articles, tables, algorithms, posters or other materials that may be used by providers and patients to improve sickle cell care. The web-based Compendium of Tools and Materials for the SCDTDP shall be delivered to the COR one (1) month prior to the end of Option Year 1.

Task 5.2 The contractor shall work with the COR to ensure all tools and materials created by the SCDTDP are web ready and can be placed on the web for accessibility by all stakeholders. The contractor shall work with the COR to identify existing structures for possible placement of SCDTDP tools and materials.

Task 6: Reporting and Communication The contractor shall be responsible for the following reports and reporting strategies:

Task 6.1 Quarterly Reporting The contractor shall submit a detailed progress report to the COR on a quarterly basis. This report shall include a complete list of all tasks and subtasks of the contract and outline progress made in the reporting period, an explanation for any delays and a revised timeline for completion of each task. Activities of the OSC and any working groups shall be outlined in the appropriate tasks.

Task 6.2 Develop Communication Strategies for External Stakeholders The contractor shall develop and implement a communication strategy for external stakeholders that allows the dissemination of project results to stakeholders external to the government and this project through multiple venues, including national list serves, peer reviewed journals, public news outlets, newsletters, and other strategies. The strategies shall include electronic and print media where cost effective.

The strategy to disseminate all tools and educational materials gathered and developed during the contract periods shall target a diverse group of stakeholder groups, including federal agencies, university medical centers, primary care providers, advocacy groups and patient groups, as well as among the general population. This shall include dissemination of a compendium of sickle cell resources and best practices that were developed during the contract.

Option Year Two Task 1: Project Management and Administration

Task 1.1 The contractor shall maintain a reporting and forecasting system detailing monthly spending, spending to date (including both direct and indirect costs), and funds remaining. This information shall be reported to the COR on a monthly basis. This report shall be submitted to the COR by the 15th of each month and shall be readily available at other times upon request.

Task 1.2 The contractor shall maintain a timeline, which includes the list of task with all sub-tasks, a list of contractor staff that are responsible for each task; and estimated completion date of each task. The timeline shall be updated regularly and used by the contractor to evaluate progress toward completion of activities in the contract. Monthly meetings between contractor and COR shall include review of progress to date on all tasks listed in the timeline. The revised timeline shall be submitted one (1) month after EDOC.

Task 1.3 The contractor shall maintain a regular contact schedule with the COR including a monthly meeting with the COR, and a quarterly meeting with the COR, Director of the Division of Services for Children with Special Healthcare Needs, and other key staff members of MCHB. The quarterly meeting shall be conducted by either conference call or in-person meeting. The contractor shall submit a brief meeting summary with action items within one (1) week of each monthly conference call and quarterly meeting.

Task 1.4 The contractor shall ensure that all travel to perform work under this contract is in accordance with the Federal Travel Regulation. The contractor shall obtain approval from the COR in advance of travel, particularly if Government rates are not attainable. When an in-person meeting or conference is planned, the contractor shall be responsible for developing and submitting a budget for the conference or meeting in advance to allow approval by the COR.

Task 2: Sickle Cell Disease Treatment Demonstration Program Oversight Steering Committee

Task 2.1 The contractor shall arrange quarterly OSC meetings by conference calls. The contractor shall provider the COR with agendas and planning materials one (1) week prior to any OSC conference calls. The contractor shall provide a conference line for each conference call and provide written summary notes with action items from each conference call to the COR within one (1) week after the calls.

Task 3: Maintenance of Data Base and Program Evaluation

Task 3.1 The contractor shall, in collaboration with SCDTDP grantees, the OSC, the COR and HRSA partners, maintain and modify the database to improve on the data collection strategies.

Task 4: Model Protocol and Strategy Development Task 4.1 Using data from the database, qualitative and quantitative data from SCDTDP grantees, and working with the SCDTDP grantees, the OSC, and the COR, the contractor shall modify the model protocol for achieving the three goals of the program: 1) to increase the number of providers treating sickle cell disease, 2) to increase the number of providers prescribing disease modifying therapies, such as hydroxyurea, and 3) to increase the number of sickle cell patients seeking regular care with knowledgeable providers. The contractor shall submit a report detailing the data that supports the updated model protocol report two months prior to the end of Option Year 2.

Task 4.2 The contractor shall develop Technical Working Groups from members of the SCDTDP grantees as needed to evaluate strategies for improving sickle cell care. The contractor shall coordinate and facilitate meetings of the Technical Working Group as needed to support the continued needs of the Sickle Cell Disease Treatment Demonstration Program grantees.

Task 5: Compendium of Tools and Materials Task 5.1 The contractor shall gather all tools and materials created by grantees and the OSC in support of the program, including the model protocol and strategies, reports, articles, tables, algorithms, posters or other materials that may be used by providers and patients to improve sickle cell care. The web-based Compendium of Tools and Materials for the SCDTDP shall be delivered to the COR one (1) month prior to the end of Option Year 2.

Task 5.2 The contractor shall work with the COR to ensure all tools and materials created by the SCDTDP are web ready and can be placed on the web for accessibility by all stakeholders. The contractor shall work with the COR to identify existing structures for possible placement of SCDTDP tools and materials.

Task 6: Reporting and Communication The contractor shall be responsible for the following reports and reporting strategies:

Task 6.1 Quarterly Reporting The contractor shall submit a detailed progress report to the COR on a quarterly basis. This report shall include a complete list of all tasks and subtasks of the contract and outline progress made in the reporting period, an explanation for any delays, and a revised timeline for completion of each task. Activities of the OSC and any working groups shall be outlined in the appropriate tasks.

Task 6.2 Develop Communication Strategies for External Stakeholders The contractor shall develop and implement a communication strategy that allows the dissemination of project results to external stakeholders through multiple venues, including peer reviewed journals, public news outlets, newsletters, national listservs and other strategies. The strategy shall include electronic and print media where cost effective.

The strategy to disseminate all tools and educational materials gathered and developed during the contract periods shall target a diverse group of stakeholder groups, including federal agencies, university medical centers, primary care providers, advocacy groups and patient groups, as well as the general population. This shall include dissemination of a compendium of sickle cell resources and best practices developed during the contract.

Task 6.3 Report to Congress The contractor shall create a report suitable in format and content as a report to Congress that includes recommendations regarding the effectiveness of the Hemoglbinopathies Learning Collaborative and the SCDTDP and measures that support all recommendations in the report. The report shall include measures of care processes and utilization among the sickle cell population in grantee catchment areas, the number of individuals served by the program, and changes in healthcare strategies or utilization as a result of the implementation of the program. A draft of the report shall be provided to the Oversight Steering Committee for review and comment prior to the contractor submitting the Report to Congress to the COR. This Report to Congress is strictly required. The Report to Congress shall be delivered directly to Congress at the end of the Option Period 2. Three final copies of the Report to Congress shall be delivered to the COR one (1) month prior to the contractor submitting the Report to Congress

Task 6.4 Presentation to MCHB Staff The contractor shall schedule and conduct a presentation on the SCDTDP and the Hemoglobinopathies Learning Collaborative, including the program outcome and evaluation, to be held at the Parklawn Conference Center or another venue in the Rockville/Bethesda area for the purpose of providing interested HRSA/MCHB and BPHC staff, as well as other federal partners and stakeholders, with verbal and written information on the outcome of the data, education and training projects and evaluation efforts for the Sickle Cell Disease Treatment Demonstration Program. The venue will be secured by the COR and no contract funds shall be used to secure the venue. Contract funds shall be used to travel required presenters to the venue. The contractor shall provide the presentation to MCHB staff one (1) month prior to the end of Option Year 2.

Optional Task The following optional task is available to be exercised only one (1) time for the life of the contract, during Option Year 2.

Optional Task A: The contractor shall be responsible for planning and conducting a conference that bring together SCDTDP grantees, OSC members, HRSA partners and other stakeholders to collect information on strategies for data collection for sickle cell disease. The conference shall be held in Option Year 2 of the Contract in the Bethesda/Rockville area. The contractor shall be responsible for submitting an agenda and proposing a method for using the conference to gather information and developing strategies to improve the SCDTDP database. The conference report shall include finding and recommendations for improving the database and data elements. The Data Conference Summary Report with Recommendations shall be submitted to the COR one (1) month after the Data Conference.