Specialized Research Support Services

The National Institutes of Health (NIH) intends to award a Firm-Fixed-Price Purchase Order to KEMRI-Wellcome Trust Research Programme for Specialized Research Support Services in support of the Kwashiorkor Collaboration Network ("KwashNet"). The Government intends to solicit from a single source in accordance with Federal Acquisition Regulation (FAR) 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. The Government anticipates awarding a firm-fixed-price purchase order for specialized research support services, including participant data collection and management, biological sample processing, DNA extraction and quantification, sample shipment to NIH, and scientific consultation in support of an international genomic study of severe acute malnutrition (SAM). The Contractor shall provide personnel with the specialized qualifications and experience necessary to perform the required work. The anticipated level of effort includes: Study Coordinator 10% Effort The Study Coordinator shall directly manage participant data and biological sample collection activities, including data quality assurance and coordination of study activities. Laboratory Technician 100% Effort The Laboratory Technician shall perform DNA isolation and quantification from a minimum of 6,000 biological samples, including samples from kwashiorkor/marasmic-kwashiorkor cases and marasmus controls. Project Administrator 10% Effort The Project Administrator shall support study logistics, procurement activities, staff management, invoices and payments, and other administrative requirements associated with performance of the project. The Government intends to solicit and negotiate with only one source because the required services can be provided by only one responsible source capable of satisfying the Government's requirements. The requirement is highly specialized and is directly dependent upon the Contractor's established research infrastructure, access to the existing biorepository and associated electronic records in Kilifi, Kenya, established relationships with the relevant study population, and specialized scientific expertise concerning severe childhood malnutrition, including kwashiorkor, marasmus, marasmic-kwashiorkor, and Kenyan populations. The proposed Contractor's designated Kenya Principal Investigator (PI) and research team possess specialized subject-matter expertise in kwashiorkor, marasmus, and the relevant Kenyan study population and have access to the existing biological samples, participant records, and associated research infrastructure necessary to execute the required work. The Government requires the Contractor to obtain and process samples from the existing population and associated biorepository records rather than establish a new population, develop new biorepository infrastructure, or independently recreate the historical medical and anthropometric information required for this study. The use of an alternative source would require establishing new participant recruitment and research infrastructure and would not provide the same access to the existing cohort, records, biological materials, historical data, and population-specific expertise necessary to meet the Government's scientific objectives within the required period of performance. Additionally, the Kenya PI's specialized knowledge of the study population is necessary to support interpretation of the research findings and appropriate dissemination of pooled, de-identified results to the affected population in Kenya in accordance with local and cultural expectations. Accordingly, the Government has determined that the proposed source is uniquely positioned to satisfy the requirement and that no other responsible source is expected to satisfy the Government's requirements without substantial duplication of effort, delay, and/or unacceptable impact on the scientific integrity and objectives of the study. Therefore, the Government i…