HHS Justification for Other Than Full and Open Competition under FAR part 6 Fertility Initiative Redacted

1. Assess fertility-related health outcomes and trends over time; 2. Identify clinical, demographic, geographic, and healthcare-utilization factors associated with infertility and other fertility-related conditions; 3. Evaluate the relationship between fertility-related conditions and chronic diseases, pregnancy complications, maternal morbidity and mortality, and other health outcomes;
4. Examine patterns in fertility assessment, diagnosis, treatment, and healthcare utilization;
5. Evaluate differences in access to fertility-related services and other relevant healthcare services;
6. Analyze maternal-infant-linked outcomes and longitudinal trends; 7. Identify opportunities for earlier recognition of fertility-related risks and underlying conditions;
8. Evaluate the effect of evidence-based interventions and healthcare practices using realworld clinical data; and 9. Provide analyses that may inform future HHS programs, research priorities, program planning, and policy development.
Performance of this requirement requires more than the delivery of a static commercial data file. The contractor must provide access to a sufficiently large historical and current healthcare dataset, maintain the source data and associated data infrastructure, apply data quality and validation processes, maintain continuity in variables and source systems across the required period of analysis, and provide technical and analytic expertise concerning the structure and appropriate use of the underlying data.
For this requirement, HHS requires a research data source capable of supporting analyses involving, at a minimum:
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inpatient, hospital-based outpatient, and emergency department encounters; longitudinal historical data sufficient to evaluate trends over multiple years; diagnosis and procedure information at a level sufficient to identify relevant fertility, reproductive, maternal, infant, and chronic health conditions; patient and encounter characteristics necessary to support appropriate stratification and analysis;
healthcare utilization and treatment information;
hospital and facility characteristics relevant to the analyses; sufficient volume and geographic breadth to support national-level and subgroup analyses;
consistent data definitions, normalization, quality-control, and validation processes across the period under study; and

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the ability to obtain technical assistance and analytic support from personnel familiar