Acute Gastroenteritis Study
The Centers for Disease Control and Prevention, NCIRD/DVD/OD, 1600 Clifton Rd. NE, Atlanta, GA, 30333, hereby announces its intent to issue a sole source contract in accordance with FAR 6.302-1 to Atlanta Research and Education Foundation, 2250 North Druid Hills Road, NE, Suite 238, Atlanta, GA 30329, to conduct a prospective analysis to better study factors related to Acute Gastroenteritis (AGE) within the Veterans Affairs (VA) Medical Centers. The specific objectives of the project are as follows:
1. Assess the incidence of outpatient visits, hospital admissions, community-acquired, and hospital-acquired acute gastroenteritis, including norovirus, rotavirus and other pathogens in VA facilities, by conducting active inpatient and passive outpatient surveillance for AGE.
2. Study the pathways of AGE transmission in the household of patients in a VA population, by conducting follow up interviews and collecting stool and serum samples from AGE cases several weeks following enrollment.
3. Other Direct Costs (ODC) include (a) testing acute and convalescent stool specimens to determine etiologies, (b) testing saliva and serum specimens to assess immune responses and HBGA expression, (c) providing patient reimbursement for study participation, and (d) assessing the relationship between the microbiome, secretor status and norovirus infection.
4. Characterize the severity of AGE and specific pathogens detected among patients with stool samples submitted for routine diagnostic testing while hospitalized by conducting inpatient passive surveillance.
5. Conduct retrospective medical chart reviews and testing of AGE stool samples collected.
6. Determine the economic burden of AGE-associated hospitalizations and outpatient visits in the VA population.
7. Conduct surveillance for ARI pathogens identified through physician-directed testing and assess outcomes of patients.
8. Collect serologic specimens from patients with pathogen-confirmed ARIs.
The statutory authority permitting other than full and open competition is 41 U.S.C. 253(c)(1) as cited in FAR 6.302-1, "Only one responsible source and no other supplies or services will satisfy agency requirements." In 1988, Congress passed Public Law (P.L.) 100-322 [now codified at sections 7361-66 of title 38, United States Code (U.S.C.)], which permitted the Secretary of Veterans Affairs (VA) to authorize the establishment of Nonprofit Research Corporations (NPC) at VA medical centers (VAMC). This laid the foundation for creation of unique partnerships to conduct VA-approved research. P.L. 100-322 allowed the establishment of private, state-chartered, nonprofit entities to provide flexible funding mechanisms for the administration of funds, other than those appropriated to VA, for the conduct of VA-approved research.
In 1999, Congress expanded the NPCs' authority to include support for VA's education and training missions. The fundamental purpose of the NPCs is to serve Veterans by supporting VA research and education in order to improve the quality of care that Veterans receive.
The Atlanta Research and Education Foundation, Inc. (AREF) is a nonprofit corporation that was created to advance the research and educational activities for the staff at the Atlanta Department of Veterans' Affairs Medical Center. AREF established an exclusive collaborative partnership with the Atlanta VA Medical Center to administer a variety of medical research programs for government agencies. As mandated by Congress with the passing of P.L. 100-322, AREF is the only non-profit corporation created to conduct and administer medical research for the Atlanta VA facilities. AREF is essential to meeting the Government's requirement to study the burden of viral gastroenteritis and acute respiratory illness in the VA patient population. The market research indicated that no other company is authorized and no other company can be modified to meet CDC's need to conduct medical research for the Atlanta VA facility.
Responsible sources that believe they possess the expertise and capabilities identified above are encouraged to submit to the Contracting Officer within 15 days from the posting date of this notice, their written capabilities statement, proposal or quotation which shall be considered by the agency. Please forward the capability statement and/or pricing information to Maria Shamburger, Contracting Officer, Reference 2019-1018, Centers for Disease Control, Procurement and Grants Office, ATTN: Maria Shamburger, MS: K14, 2920 Brandywine Road, Atlanta, GA 30341. All vendors must be registered in the System for Award Management (SAM) prior to an award of a federal contract. The website is: www.sam.gov.
The Government will review any/all capabilities statements and pricing information submitted and determine if other qualified sources do exist that could provide this requirement. Information received in response to this announcement will be used solely for the purpose of determining whether to conduct a competitive procurement.
If no affirmative responses are received within 15 days, negotiations will be conducted with the Atlanta Research and Education Foundation as the only source and a contract will be issued without any additional notices being posted.
Maria S Shamburger, Email HEG9@cdc.gov
