The Veteran s Administration (VA) Office of Research and Development, Regional Procurement Office East in Pittsburgh, PA intends to negotiate on a sole source basis with the Center for Infection and Immunity at the Columbia University Mailman School of Public Health based in NY on behalf of the Madison WI Healthcare System. The requirement is to provide research assistance for planned VA medical studies. The planned studies focus on Post-Exertion Malaise in Gulf War Illness: Brain, Autonomic and Behavioral Interaction, and the proposed extension of this project, require lab services for the purpose of conducting genetic, epigenetic, transcriptomic, proteomic, metabolomic, microbiologic, and serologic analyses of blood and plasma samples. To optimize results and minimize inconsistencies, the requirement is to incorporate TruCulture blood collection and processing procedures. Study personnel responsible for blood sample collection and processing at the Madison VA and the collaborative site, the War Related Illness and Injury Study Center at the East Orange campus of the VA New Jersey Health Care System (WRIISC), require training on the equipment and procedures prescribed under TruCulture protocols. The project also requires expert scientific consultation on the interpretation of the resulting data and statistical analysis of these data in order to integrate the findings from each of the measures into a comprehensive evaluation. In addition, the contractor will assist in the formation of presentations and manuscripts to disseminate project results to the public. The action will be awarded as a new Indefinite Delivery/Indefinite Quantity contract with firm-fixed-price task orders. The planned studies follow preliminary studies based on the same subject. The specific work to be performed includes: 5. Specific Tasks. 5.1 Task 1 The contractor will provide necessary supplies to complete TruCulture blood collection and preliminary processing at the Madison VA and New Jersey WRIISC and will consult with personnel at both sites to ensure correct and standardized procedures 5.1.1 The contractor will advise personnel at both sites on all necessary equipment for the TruCulture sample collection and processing procedures 5.1.2 The contractor will order and ship the necessary supplies to conduct TruCulture collection for both sites 5.1.3 The contractor will verify tissue sample quality from each site using the TruCulture methodology and will work to address any suspected deviations from the prescribed procedures for the duration of the contract 5.1.4 The contractor will also provide support to the Madison VA and New Jersey WRIISC personnel for the duration of the contract in order to maintain sample quality and integrity 5.2 Task 2 The contractor will provide necessary supplies to complete the collection and shipping of blood and plasma samples, in addition to the TruCulture samples, from the Madison VA and New Jersey WRIISC for analyses and will consult with personnel at both sites to ensure correct and standardized procedures 5.2.1 The contractor will advise personnel at both sites on all necessary equipment for the blood and plasma sample collection 5.2.2 The contractor will order and ship the necessary supplies to conduct blood and plasma collection for both sites 5.2.3 The contractor will verify tissue sample quality from each site and will work to address any suspected deviations from the prescribed procedures for the duration of the contract 5.2.4 The contractor will also provide support to the Madison VA and New Jersey WRIISC personnel for the duration of the contract in order to maintain blood and plasma sample quality and integrity 5.3 Task 3 The contractor will provide results from comprehensive metabolomic analyses of previously and to be collected blood plasma samples from participants of the parent project and its extension 5.3.1 Duplicate testing of as many as three (3) plasma samples, each representing a different time point, will be analyzed for each of the 180 anticipated participants 5.3.2 For optimal resolution, the contractor will perform three untargeted metabolomic assays and one targeted assay for 5,122 metabolites representing primary metabolites, biogenic amines, complex lipids, and bioactive oxylipins, while filtering for possible confounding factors (e.g., medication) 5.3.3 For each participant at each of the three timepoints, results for primary metabolites, biogenic amines, and complex lipids will be normalized by the sum intensity of all annotated metabolites 5.3.4 For each participant at each of the three timepoints, results for bioactive oxylipins will be reported in absolute concentrations (e.g., nanomoles/L) 5.4 Task 4 The contractor will provide results from comprehensive proteomic analyses of previously and to be collected blood plasma samples from participants of the parent project and its extension 5.4.1 As many as three (3) tissue samples, each representing a different time point, will be analyzed for each of the 180 anticipated participants 5.4.2 The results of the proteomic analyses will provide the investigators with protein expression profile information for all usable samples 5.4 Task 5 The contractor will provide results from comprehensive epigenetic analyses of blood samples to be collected using the TruCulture methodology from participants of the parent project and its extension 5.5.1 Samples will be analyzed for each on the 100 anticipated participants providing TruCulture collected tissue 5.5.2 The contractor will sequence bisulphite-treated DNA libraries for all usable samples in order to establish DNA methylation status, permitting the investigators to test for differential DNA methylation between our participant groups 5.5 Task 6 The contractor will provide results from transcriptomtic analyses (i.e., RNA sequencing) of blood samples to be collected using the TruCulture methodology from participants of the parent project and its extension 5.6.1 Samples will be analyzed for each on the 100 anticipated participants providing TruCulture collected tissue 5.6.2 The contractor will complete a quantitative trait analysis with a centered focus on immune cell dysfunction and altered metabolic properties of peripheral blood cells permitting the investigators to test for differences between our participant groups 5.7 Task 7 The contractor will provide results from microbiologic analyses (i.e., Luminex) of blood samples to be collected using the TruCulture methodology from participants of the parent project and its extension 5.7.1 Duplicate testing of samples will be analyzed for each on the 100 anticipated participants 5.7.2 The results of the analyses will provide data on the expression of soluble immune factors in response to stimulation with mimics of bacterial, viral and fungal infection 5.8 Task 8 The contractor will provide results from serologic analyses of previously and to be collected plasma samples from participants of the parent project and its extension 5.8.1 Enterovirus peptide array analyses will be conducted for each of the 180 anticipated participants providing tissue samples 5.8.2 The results of the analyses will provide data on the enterovirus exposure and permit investigators to evaluate differences in exposure between groups 5.9 Task 9 The contractor will purchase all necessary supplies for use at their site in order to complete the lab services requested (i.e., Tasks 3-8) 5.9.1 The contractor will purchase all supplies necessary for the conduction of the contracted analyses as they are needed 5.9.2 The contractor will invoice the Madison VA for costs associated with the supplies used in the completion of the lab services requested 5.10 Task 10 The contractor will provide expert scientific consultation on the interpretation of the resulting data and statistical analysis of these data 5.10.1 The contractor will work with project staff to develop a comprehensive evaluation of the resulting data 5.10.2 This consultation will include guidance on statistical analyses, including topological data analysis of the integrated results 5.10.3 The contractor will provide reference data from similar patient populations for the purpose of informing the interpretation of the findings from the present project and its extension 5.11 Task 11 The contractor will aid in and contribute to preparations of presentations and manuscripts intended to disseminate the results of the project and its extension to the public 5.11.1 Consultation on results interpretation and statistical analyses will extend to the preparations of formal scientific presentations and peer-reviewed publications The requirement will be led by the Madison VA, but most services take place at a VA facility in Orange, NJ. The sole source is pursuant to FAR 6.302-1 Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. This notice of intent is not a request for competitive proposals, however; any responsible source who believes it is capable of meeting the requirement may submit a capability statement and supporting documentation to the contracting office no later than Monday, Dec 11, 2023, (10:00 AM, EST). Interest/capability statements may be sent to Michael Haydo at
[email protected]. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government.