Draft SOW for Notice of Intent_REQT-OMAS-MS-2026-00085.pdf

Draft Statement of Work

HHS Fertility Data and Analysis Initiative Contract

TASK REQUIREMENTS

Task 1.0 Project Planning and Management

Subtask 1.1: Kick-Off Meeting

The Contractor shall meet with the Contracting Officer’s Representative (COR) and Project Officer (PO) within two (2) weeks after base and option year awards to ensure clarification of project goals, scope of work, routine communication standards, quality control standards, and deliverable and invoice submissions. The purpose of the meeting will be to discuss the objectives of the task order and to reach a common understanding of how the contractor will complete the work, the timelines, and the deliverable schedule for projects under this task order. The contractor shall be prepared to discuss critical activities requiring immediate attention and the project execution process. The COR and PO may also discuss anticipated requests with the contractor. The contractor may provide COR with a list of questions or issues in advance of the Kick-Off meeting. After the meeting, the contractor shall submit a memo to the COR summarizing the meeting and any decisions made.

Deliverable(s): (A) Kick-Off Meeting (B) Meeting Summary Memo

Subtask 1.2: Weekly COR and PO Meetings

The contractor shall prepare a draft project management plan for the contract that details the intended approach to supporting the women’s health portfolio during the period of performance. The management plan shall be brief (up to 5 pages) and include: an overall approach to performing tasks and managing projects, plans for communication, processes for budget and cost estimation, and a plan for how to resolve any issues that present themselves over the task order period of performance (i.e., changes in key personnel, delays in obtaining critical data).

The task order management plan shall specify: the contractor’s strategy for planning and preparing analytic products on short, medium, or long-term projects; how appropriate or necessary analysts, experts (including academic or other institutions), or sub-contractors are identified, and a strategy for conducting any data or policy analysis that may be requested for work products, including a process for receiving input from the COR and/or PO during the development of each product.

The task order management plan shall also include draft elements for the monthly progress report and a template for the budget report (Subtask 1.4).

Deliverable(s): (A) Draft Task Order Management Plan (B) Final Task Order Management Plan

Subtask 1.3: Project Work Plan

The COR and/or PO will submit a project request to the contractor for each specific project under this task order, including background information, research questions to be addressed, tasks, and a draft schedule of deliverables. Upon receipt of the request, the contractor may request a meeting with the COR and PO assigned to the project to determine the specific scope and proposed approach for each project. These meetings may take place via a video conferencing platform (e.g. Microsoft Teams, Zoom, Webex), email, conference call, or in conjunction with a weekly conference call (Subtask 1.4), and may occur as needed over the course of the project. Each project (See Task 2) will require a project work plan and a proposed subject matter team of experts.

The contractor shall draft a project work plan for each project request, submit it to the COR and PO for review and approval within two (2) weeks of receipt, and host a meeting to discuss it. The project work plan shall detail the project's technical approach and schedule (see Task 2). Specifically, the project work plan shall include a description of the technical approach; any anticipated challenges to completing the project and how the contractor will address them; staffing and management responsibilities; and the allocation of project resources, including projected hours per staff member. The project work plan shall also include a timeline that identifies the start and completion dates, as well as other milestones, for each deliverable specified in the plan. The project work plan shall be based on the project request from the COR and PO, as well as discussions and other decisions made at the project work plan meeting. The COR and PO may modify the project work plan, including completion dates, after consultation with the contractor, if needed. All approved project requests must be completed by the end of the contract's period of performance or discontinued by mutual agreement of the contractor, the COR, and the PO.

Draft project work plans shall be submitted to the COR and PO for review and approval no later than two (2) weeks after the project work plan development meeting or otherwise agreed upon by the COR and PO. Upon incorporating comments from the COR and PO and final approval by the COR and PO, a final work plan shall be submitted to the COR and PO no later than one (2) weeks after final approval.

Deliverable(s): (A) Draft, (B) Final Project Work Plan(s), as needed

Subtask 1.4: Standing Project Management Conference Calls

Standing conference calls between the contractor, the COR, and the PO shall be scheduled within one week of the EDOC. The contractor, the COR, and the PO will decide on the periodicity of project management calls, which may change during the contract period to reflect HHS’s evolving needs, but should be assumed to occur weekly. During each call, the contractor shall be prepared to discuss any issues that have arisen since the last monthly progress report (Subtask 1.5) and to provide key updates on current projects, including any changes to the estimated budget or costs. The contractor shall develop an agenda prior to the call and, within one week, distribute the meeting minutes, including key points and decisions, to the COR and PO.

Deliverable(s): (A) Standing Call Agendas (B) Standing Call Action Items Summaries

Subtask 1.5: Monthly Progress Reports

The contractor shall submit monthly progress reports (not to exceed four (4) pages, excluding tables or charts) outlining all work accomplished during the previous month. At a minimum, such reports should cover the following items:

• Discussion of the progress in accomplishing the tasks specified in this task order.

• Difficulties encountered and remedial action(s) taken.

• Activities anticipated during the upcoming reporting period.

• Personnel and other management changes.

Monthly progress reports are due within the first week of each month following the Kick-Off Meeting (Subtask 1.1), or as otherwise agreed upon by the COR and the contractor and shall be sent by the Principal Investigator directly to the COR via email. Monthly progress reports should specify the use of funds by project, including staff hours for each project and for overall administration of the task order.

Deliverable(s): (A) Monthly Progress Reports

Task 2.0 Data Collection, Analysis, Research, and Reporting

The Contractor will develop a 5-year Strategic Plan and an annual Work Plan that outlines an approach for conducting an in-depth analysis of women’s and men’s fertility, infertility treatment, and linked infant health outcomes, including inpatient and outpatient data, as outlined in Tasks 2.0–4.0.

The Contractor shall conduct nationally representative analyses of women’s and men’s fertility, infertility treatment, and linked infant health outcomes in support of HHS research priorities identified in the approved Strategic and Work Plans.

Using standardized inpatient, outpatient, and linked research databases, the Contractor shall analyze factors associated with fertility and related health outcomes, including chronic conditions, disease severity, comorbidities, and complications, stratified by patient demographics (geographic location, socioeconomic status, race, and ethnicity), treatment patterns, environmental factors, and costs.

The Contractor shall apply advanced analytic methods, including biostatistics, regression, microsimulation, and cost analyses, to assess fertility-related outcomes; estimate the costs, benefits, and impacts of HHS policy proposals; identify innovations, market trends, opportunities, and knowledge gaps; evaluate HHS-wide initiatives; and provide adjusted, unadjusted, and routine analyses throughout the contract period.

The Contractor shall provide technical assistance and related work products, including quantitative and qualitative analyses, written reports, data extracts, and routine briefings

Deliverables: A. Access to ongoing fertility-related inpatient, outpatient, and linked data analyses, as specified in the approved Strategic and Work Plans; B. Annual and quarterly fertility analysis and outcome extracts; C. Technical assistance; D. Annual fertility data research and outcome reports; E. Advanced analytic methods specified in the Work Plan;

F. Analyses of fertility-related health outcome relationships; and G. Fertility-related cost analyses. H. Develop 5-year Strategic Plan and Annual Work Plans

Subtask 2.1: National HHS Fertility Data and Research Analysis

Implement HHS Fertility Data and Analysis using a nationally representative research database to examine factors contributing to U.S. fertility, including the role of chronic conditions, stratified by patient demographics (geographic, race, ethnic, and socioeconomic factors), disease severity, comorbidities, complications, and resource utilization.

The Contractor shall analyze and measure data using advanced data technologies and biostatistics methods, including regression analyses and microsimulation modeling, to address requested HHS research topics as specified in the Work Plan, such as:

• Understanding the relationship between various pre-existing conditions and other risk factors, complications, fertility, and fertility treatment outcomes.

• Estimating the costs and benefits of women, men, and infant policy proposals under consideration by HHS

• Work with HHS on women's and men's health innovations, market trends, and opportunities to identify knowledge gaps for quantitative and qualitative analysis.

• Assessing outcomes that are the focus of HHS-wide initiatives.

• The Contractor shall conduct ongoing comprehensive analyses of men, women, and infants addressing, at a minimum, the following domains:

o Physical health and chronic conditions, including infertility, diabetes, endocrine disorders, cardiovascular disease, obesity, pregnancy complications, and long-term health outcomes.

o Mental health conditions, including anxiety, depression, chronic stress, and associated pregnancy and long-term health outcomes.

o Nutrition, including its relationship to men’s and women’s fertility, pregnancy outcomes, infant health, and chronic conditions.

o Medication and Substance use and lifestyle factors, including exercise, tobacco, alcohol, and drug use before and during fertility treatment and pregnancy.

o Access to care, including fertility care utilization, routine screenings, and ongoing management of chronic and reproductive health conditions.

o Demographic factors, including healthcare access, environmental conditions, and socioeconomic factors affecting fertility and health outcomes.

The Contractor shall provide adjusted and unadjusted analyses from a nationally representative, standardized inpatient database on women's and men’s fertility data, including linked infant health outcomes, annually, as described in the Strategic and Work plans.

The Contractor shall analyze up-to-date data describing the relationships between women's and men’s fertility and associated health outcomes throughout the contract, and report findings on a routine basis.

The Contractor shall analyze data and perform cost analyses of women's and men’s fertility healthcare, including fertility treatment and management, with respect to health outcomes.

The Contractor shall provide technical assistance and develop work products, including various quantitative and qualitative analyses and associated written documents.

The Contractor shall routinely analyze data to evaluate the relationship between women's and men’s fertility health across the continuum, including contributing factors such as treatment, management, environmental impact, and chronic conditions.

The Contractor shall, in addition to the above analysis, conduct four focused drills and provide adjusted and unadjusted analyses of fertility data for women and men, along with supporting reports, briefs, or manuscripts, as directed by HHS.

The Contractor shall develop an outcome dashboard to display annual rates of identified outcomes as identified in the Work Plan and provide all analysis tables, graphs, and visualizations associated.

Task 2.1 Deliverable(s): A. Access to ongoing women's and men’s fertility inpatient and outpatient and infant linked data research analysis as specified in the agreed-upon Strategic and Work Plans B. Annual and Quarterly women's and men’s fertility analysis and outcome extract C. Technical assistance D. Annual women's and men’s fertility data research analysis outcome reports E. Analyze and measure data using advanced methods specified in the Work Plan F. Analyze data describing relationships G. Analyze data describing cost H. Four (4) annual ad-hoc adjusted and unadjusted analyses on women's and men’s fertility annually. I. Provide Outcome Dashboard, updated annually, along with all analysis, tables, graphs, and visualizations.

Subtask 2.2: HHS Fertility Impact Collaborative

The Contractor shall establish and maintain the HHS Fertility Impact Collaborative (HHS FIC), a national learning network comprising at least 75 inpatient and outpatient healthcare sites, systems, clinics, and providers to implement and evaluate targeted strategies to address the root causes of infertility. The HHS FIC shall implement, support, and evaluate evidence-based fertility practices and interventions designed to address factors associated with infertility and improve fertility-related outcomes for women and men.

The Contractor will provide a nationally representative sample and prioritize HHS FIC recruitment in diverse, underserved, rural, and tribal communities.

The Contractor shall use the HHS FIC to collect, analyze, and report data on fertility-related outcomes; implementation of evidence-based practices; resource utilization; costs;

medication use; screening, prevention, treatment; complications; and contributing chronic conditions.

The Contractor shall provide participating sites with data feedback, quality-improvement support, and web-based implementation and outcome dashboards to support implementation and performance monitoring.

The Contractor shall provide HHS with web-based dashboards presenting fertility-related health outcomes and implementation measures derived from routine analyses of inpatient and outpatient data. Dashboards provided to HHS shall include comprehensive, aggregated, de-identified analyses of men’s health, women’s health, and, as available, linked maternal-infant data. Dashboard metrics shall include, but are not limited to, national measures, fertility rates, birth outcomes, complications, chronic conditions, and associations with morbidity and mortality across the lifespan, as described in the Work Plan.

The Contractor shall conduct baseline and follow-up assessments at participating sites to evaluate changes in outcome measures and in the adoption of expected and evidence-based fertility practices and processes. Baseline assessments shall occur when a site joins the collaborative, and follow-up assessments shall occur upon site departure and/or at the conclusion of the initiative.

The Contractor shall routinely update HHS FIC practices and processes to reflect current scientific evidence, clinical guidance, technological advancements, and subject matter expertise. Where feasible, the Contractor shall align HHS FIC activities with the HHS Perinatal Improvement Collaborative (PIC) to assess the relationship between fertility health interventions and maternal and infant-linked health outcomes.

The Contractor shall synthesize and analyze the landscape of women’s and men’s fertility measures, best practices, and intervention data to support program evaluation and continuous quality improvement.

The Contractor will conduct ongoing quantitative and qualitative analysis to assess, but not limited to, the following:

• Prevalence of infertility among the population.

• Patient demographic, socioeconomic, and clinical characteristics.

• Rates of chronic and underlying conditions associated with infertility.

• Screening and diagnosis rates.

• Treatment initiation rates.

• Referral completion rates.

• Treatment patterns and costs.

• Patient and provider satisfaction.

• Financial impact on patients, providers, and systems.

• Treatment success indicators, where available.

• Changes in standard-of-care practices.

The Contractor shall provide member sites with education, training, data feedback, and technical assistance to support implementation of fertility-related quality improvement strategies.

The Contractor shall provide, in addition to the above analysis, two (2) ad hoc HHS FIC analyses, focused data drills, and supporting reports as directed by HHS annually.

Task 2.2 Deliverable(s): A. Established and maintained the HHS Fertility Impact Collaborative. B. Recruitment and maintenance of at least 75 participating healthcare sites. C. Pre-and post-collaborative site assessments. D. Updated expected and evidence-based fertility practices and processes. E. Data collection describing the impact of interventions on fertility and related health outcomes. F. Provide web-based fertility outcome and implementation dashboards to FIC sites and HHS as described in the Work Plan. G. Analysis of fertility health measures and best practices. H. Analysis of fertility health intervention data. I. Annual HHS FIC statistical data extract and quarterly trended fertility analysis data extract. J. Provide HHS FIC sites with education, training, data feedback, and technical assistance to support implementation of fertility-related quality improvement strategies.

Subtask 2.3: HHS Fertility Initiative Impact on Maternal and Infant Health

The Contractor shall assess the impact of the HHS Fertility Data and Analysis Initiative on linked maternal and infant health and, as available, by aligning fertility-related measurement, analysis, and quality-improvement activities with the HHS Maternal Morbidity and Mortality Data Analysis Initiative, including the HHS Perinatal Improvement Collaborative (PIC), as described in Task 2.2 and the Work Plan.

The Contractor shall use linked maternal-infant data, inpatient and outpatient data sources, and cross-continuum care measures to evaluate fertility-related health conditions, interventions, utilization, and outcomes across communities and clinical settings. This analysis shall support the identification of pregnancy-related risks and adverse outcomes, and the development of evidence-based strategies to improve health outcomes for women, men, and their infants across the lifespan.

The Contractor shall conduct comprehensive analyses of men, women, and infants addressing, at a minimum, the following domains:

• Physical health and chronic conditions, including infertility, diabetes, endocrine disorders, cardiovascular disease, obesity, pregnancy complications, and long-term health outcomes.

• Mental health conditions, including anxiety, depression, chronic stress, and associated pregnancy and long-term health outcomes.

• Nutrition, including its relationship to men’s and women’s fertility, pregnancy outcomes, infant health, and chronic conditions.

• Medication, substance use, and lifestyle factors, including exercise, tobacco, alcohol, and drug use before and during fertility treatment and pregnancy.

• Access to care, including fertility care utilization, routine screenings, and ongoing management of chronic and reproductive health conditions.

• Demographic factors, including healthcare access, environmental conditions, and socioeconomic determinants affecting fertility and health outcomes.

The Contractor shall identify and routinely update evidence-based strategies to reduce morbidity and mortality among women and infants. The Contractor shall also conduct pre-and post-collaborative assessments to measure adoption of evidence-based clinical practices and processes at participating sites.

The Contractor shall provide web-based fertility health outcome and implementation dashboards presenting fertility-related health outcomes and implementation measures derived from routine analyses of inpatient and outpatient data. Dashboards provided to HHS shall include comprehensive, aggregated, de-identified analyses of men’s health, women’s health, and, as available, linked maternal-infant data. Dashboard metrics shall include, but are not limited to, national measures, fertility rates, birth outcomes, complications, chronic conditions, and associations with morbidity and mortality across the lifespan, as described in the Work Plan.

Task 2.3 Deliverable(s): A. Align HHS FIC quality-improvement measurement strategies with HHS PIC. B. Identify hospitals participating in the HHS FIC and HHS Maternal Mortality and Morbidity Data and Analysis Initiative capable of supporting cross-continuum health measurement. C. Identify and routinely update evidence-based strategies. D. Conduct pre-and post- HHS FIC and Maternal Mortality and Morbidity Data and Analysis Initiative outpatient and inpatient baseline assessments. E. Provide annual statistical reports, quarterly trended women’s, men’s, and maternal-infant linked outcome analyses, and related data extracts. F. Provide HHS with aggregated, de-identified web-based fertility dashboards.

Task 3.0 Publication Collaboration

The Contractor collaborates with HHS OWH and OMH to draft manuscripts, communication documents, and reports that convey data and analysis results to stakeholders across diverse distribution media (including, but not limited to, peer-reviewed scientific journals, data briefs, public communications, web networks, website posts, and social media channels).

The publication of manuscripts, white papers, briefs, and reports will be mutually discussed by HHS and the Contractor. HHS OWH and OMH will lead all decisions about authorship and journal preference, in consultation with the Contractor. Note: This does not include reports/analysis as outlined in Tasks 2.0 – 2.3.

The Contractor shall, in collaboration with HHS, support the development of additional manuscripts, white papers, briefs, and/or reports to facilitate the development and submission of at least four (4) peer publications annually, as outlined in the Strategic and Work Plans.

The Contractor and any consultants and subcontractors shall not release, publish, or disclose, verbally or in writing, information pertaining to the results or findings of work (including data collection, analyses, draft or final papers and reports) for the period of this contract without obtaining prior written approval of the COR or their designee. Similarly, unless authorized, information shall not be shared with the collaborating hospitals, except for data about their own hospitals.

The Contractor must request approval in advance (at least 21 days prior to release) and in writing, specifying: who or what is requesting the information; when and how the project results/information will be released; and what information will be released. Failure to receive a response from the COR or designee does not constitute approval for releasing the information.

The joint publication shall cease upon the termination of the contract, when all data has been transferred to HHS through a designated mechanism. Additional analysis of HHS-funded data is not permitted after the contract ends.

Task 3 Deliverable(s): Manuscript, White Paper, Briefs, and Report development of at least 8 publications annually, as mutually determined and outlined in the Strategic and Work Plans.

Task 4.0 Transition Plan and Data Migration

The Contractor shall develop a project transition plan that includes a detailed overview of the project, objectives and timelines, identification of key (streamlined) staff and their roles, a thorough risk assessment, and a communication plan to ensure a smooth handover to the Government, No Later Than 90 days of the contract performance end date.

The plan shall include reference materials that serve as the “Standard Operating Procedures” for HHS.

The Contractor shall design the migration in collaboration with the COR, No Later Than 75 days of the contract performance end date. The plan shall specify the file format (e.g., Excel/Tableau/Power BI), software requirements, and file organization by data source (i.e., national vs. collaborative). The migration portion of the plan shall specify which data will be moved, detail the technical architecture and processes, and provide timelines. The Contractor shall consult the COR on compatible key aspects of this design, identify the tools and resources needed, determine the necessary security standards, and establish data quality controls. The plan shall recommend size and compliant data storage requirements. The recommendation must be approved by OASH OCIO stakeholders prior to implementation. All items in the plan must be accepted by the COR before migration activities begin.

For Data Migration:

The Contractor shall assess the source data. The Contractor shall summarize the size, stability, and format of the data planned for migration to the Government, No Later Than 80 days prior to the contract performance end date. A complete audit of source data shall identify inaccurate or incomplete data fields, obsolete coding, errors, and the adapted codebook (data dictionary).

The Contractor and the COR shall brief key stakeholders, including members of the OASH OCIO teams, No Later Than 70 days of the contract performance end date. The Contractor and COR shall discuss the project goals, key milestones, and any elements that may affect these teams with the relevant stakeholders and receive feedback that may require adaptations to the project. The Contractor shall complete necessary adaptations and revisions No Later Than seven business days.

The Contractor shall develop the migration logic designed to extract, transform, and load data into the new repository, No Later Than 60 days of the contract performance end date.

Given this is a large dataset, the migration shall be staged into sections and tested section by section to ensure complete and optimal functionality.

The Contractor shall host test sessions with the COR and designated end users once the code is received in the production environment, No Later Than 50 days of the contract performance end date.

Following the test sessions, the Contractor shall perform the necessary remediation activities to ensure the data migration is fully implemented, sustainable, and acceptable to the Government, No Later Than 45 days after the contract performance end date.

The Contractor shall conduct data validation testing in collaboration with end users identified by the COR, No Later Than 40 days of the contract performance end date. The Contractor shall verify that all required data has been transferred, that the correct values are in the destination tables, and that other identified repositories are updated no later than 30 days after the contract performance end date. If any data is lost, the Contractor shall identify how the data will be recovered within three business days of discovery and make it accessible to the Government.

The Contractor shall provide all documentation related to HHS-purchased data and associated methodologies, including Glossaries, Measure Codes, and Reference Documentation.

The Contractor shall shut down and dispose of the dashboards and other tools or systems that supported the source data, and “sever” the proprietary data feeds within the current dashboards from their data platform prior to migration. Information and/or data must be disposed of in accordance with NIST SP 800-88, Guidelines for Media Sanitization. HHS will provide the Contractor with disposition instructions for securely transferring and/or destroying any agency records used in performing this contract that are in the Contractor's (or any subcontractor's) custody or control upon completion of contract performance.

Contractor shall transfer all applicable materials and supplies that are the property of the Government or purchased, throughout the life of the contract, on behalf of the Government

All applicable data and materials shall be transferred in the format agreed upon by the parties.

Deliverable(s): Transition Plan and Data Migration as specified in the Strategic Plan, Data mapping documentation, and Final Migration Report certifying completeness and accuracy.