S203--Home Delivery Meal Service for Study on Heart Failure 36C24E26Q0002

Pre-Solicitation Notice to solicit for a vendor to provide a home delivery meal service to ship nutritionally restricted meals to Veterans homes shipping three (3) meals per day for six weeks. The purpose of this multi-center clinical trial is to study the efficacy and safety of providing nutritional support shortly after discharge compared to the study-defined standard of care alone. The study-provided meals will follow a sodium-restricted Dietary Approaches to Stop Hypertension (DASH) eating pattern, which has been associated with lower heart failure (HF) incidence and greater survival in patients with HF. The vendor shall deliver meals within 1-3 days (with exceptions of holidays, Sundays) from the date of order anywhere within the 48 continental United States with the capacity to ship up to 21 meals per week per patient. The meals need to meet study-specified nutritional requirements. Meals must be provided to cover a 42-day period, i.e., 6 weeks, for each of the 700 study participants, over a period of up to 48 months with the detailed time varying by participant s enrollment status. Vendors must meet VA regulations on the transfer and storage of personally identifying information. This is not a solicitation. The Department of Veterans Affairs intends to solicit a Fixed Price Indefinite Delivery Indefinite Quantity contract for a base period of four (4) years. The period of performance will begin when funding is available. The overall goal is to meet the research study team goals of providing three meals per day for six weeks for each patient enrolled in the study for up to 700 participants in total. This is up to the four-year period in accordance with the Statement of Work (SOW) that will be included with the Solicitation. The solicitation will be issued as a total small business set-aside and will open on or about 11/05/2025 closing on or about 11/26/2025. The applicable NAICS code is 624210 with a $19.5 million size standard. The FSC/PSC is S203. Interested SDVOSBs/VOSBs must be actively verified and registered in the SBA certification database https://veterans.certify.sba.gov to receive an evaluation credit. Copies of the solicitation will not be available for mailing. All prospective Vendors must be registered in the System for Award Management (SAM) for all awards at (https://sam.gov/) at time of quotation submission and at time of award. Questions concerning this procurement may be directed to the Contracting Officer Ann Marie Stewart at annmarie.stewart@va.gov.

CSP 2025 Geriatric Out-of-hospital Randomized Meal Trial in heart failure: Veterans Affairs (GOURMET-VA) is a research study sponsored by the Department of Veterans Affairs (VA) Cooperative Studies Program (CSP). The purpose of this multi-center clinical trial is to study the efficacy and safety of providing nutritional support. The study-provided meals will follow a sodium-restricted Dietary Approaches to Stop Hypertension (DASH) eating pattern, which has been associated with lower heart failure (HF) incidence and greater survival in patients with HF. Intervention arm participants will receive home-delivered meals for a period of 6 weeks post-discharge.

RFQ 36C24E26Q0002 Q&A LOG Geriatric Out-of-Hospital Meal Delivery Trial in Heart Failure Have any amendments or updates been made to the Statement of Work (SOW) since its initial release? No 2. Will the government be using specific performance metrics or KPIs to evaluate contractor success? In monthly reports, the study team will request at minimum: number of orders placed, number of orders fulfilled, number of delayed orders and reason for delay, customer service complaints and requests from study participants made to contractor, shipping time in days for orders fulfilled. 3. Is there a ceiling price, budget range, or estimated value associated with this contract? Yes, $1,500,000.00 for the total four years. 4. Should we include separate pricing for optional services or contingencies, such as veteran phone support or printed materials? No, this should be covered under the purchase of meals. 5. What is the anticipated award date and expected start of performance? January 2026 time frame. 6. Are there any critical milestones, phased deliverables, or onboarding timelines we should be aware of? No 7. Will there be flexibility in the delivery schedule in the event of unforeseen delays? No, the vendor shall deliver meals within 1-3 days (with exceptions of holidays, Sundays) from the date of order anywhere within the 48 continental United States with the capacity to ship up to 21 meals per week per patient. The meals need to meet study-specified nutritional requirements. Meals must be provided to cover a 42-day period, i.e., 6 weeks, for each of the 700 study participants, over a period of up to 48 months with the detailed time varying by participant s enrollment status. 8. Is there a small business subcontracting goal or requirement associated with this solicitation? The limitations of subcontracting applies to the requirement. FAR Clause 52.219-14 establishes limitations on subcontracting for small business contractors, requiring them to perform a certain percentage of the contract work themselves to ensure they are not merely pass-through entities for larger firms. Small business contractors must perform at least 50% of the cost of contract performance incurred for personnel with their own employees. 9. Are Letters of Commitment from subcontractors required at the time of proposal submission? No 10. Will the contractor be required to submit monthly or quarterly performance or compliance reports? If so, what format is preferred? The contractor must provide the study team with monthly reports of the orders fulfilled under the study-related account; email preferred. 11. Are there any mandatory training or certification requirements for personnel assigned to this contract? No 12. Will there be a Q&A period or pre-proposal conference scheduled prior to the submission deadline? The question period was to email questions to the Contracting Officer no later than 11/12/2025. Responses are due back through an amendment posted on or before 11/19/2025. 13. What is the expected response time after task order issuance for scheduled and unscheduled transports? The vendor shall deliver meals within 1-3 days (with exceptions of holidays, Sundays) from the date of order anywhere within the 48 continental United States with the capacity to ship up to 21 meals per week per patient. The meals need to meet study-specified nutritional requirements. Meals must be provided to cover a 42-day period, i.e., 6 weeks, for each of the 700 study participants, over a period of up to 48 months with the detailed time varying by participant s enrollment status. 14. Are there specific delivery windows or blackout periods (e.g., holidays, weekends) we should plan around? The vendor shall deliver meals within 1-3 days (with exceptions of holidays, Sundays) from the date of order anywhere within the 48 continental United States with the capacity to ship up to 21 meals per week per patient. The meals need to meet study-specified nutritional requirements. Meals must be provided to cover a 42-day period, i.e., 6 weeks, for each of the 700 study participants, over a period of up to 48 months with the detailed time varying by participant s enrollment status. 15. Will deliveries be required at multiple locations or centralized? Can the government provide a geographic breakdown of service areas? Deliveries will be required to multiple locations. Meals are required to be delivered to the participants home address Anywhere within the 48 continental United States. The service area is anywhere within the 48 continental United States depending on where each participant lives. 16. Is advance notice required before each transport or delivery? The VA study team must be able to track each delivery once it has been shipped. 17. Are there any specific packaging requirements, such as labeling, temperature control, or tamper-proof seals? Yes, Vendor personnel must be compliant with all applicable food safety laws and HIPPA regulations, Vendor must ensure food stability, safety, and quality maintenance during delivery process. 18. Should each transport or delivery include printed instructions or documentation? Yes 19. Is proof of delivery (POD) required for each transport? If so, what format is acceptable? Study team must receive proof of delivery for each transport. The acceptable format can include: tracking number of the shipment provided to the study team, delivery email directly to the study team, or study team access to the vendor s internal tracking system for the study participants. 20. Will the government require real-time tracking or delivery confirmation? Vendor must have a system to track the delivery once sent out for shipping and must have the ability to share this information with study team and study participants. Vendor must be able to provide a regular monthly report to the study team of orders fulfilled under study-related accounts. 21. Should delivery logs be submitted monthly, per task order, or in real time? Delivery logs must be submitted monthly. Vendor must be able to provide a regular monthly report to the study team of orders fulfilled under study-related accounts. 22. What is the protocol if transport is delayed or a vehicle is damaged? A replacement meal delivery will be sent to the participant as soon as possible at no cost to the government. 23. Will the contractor be responsible for re-delivery at no additional cost in such cases? Yes 24. Will transport be made to residential addresses, government facilities, or both? Residential addresses only. 25. Is there a preferred method for notifying the government of transport delays or service disruptions? Email notification as soon as the contractor becomes aware of the delay or disruption. 26. Will the contractor be required to provide customer service support to veterans or VA staff? Yes, both 27. When is the anticipated start date or contract period? January or February 2025 time frame. 28. Are the patients local to Connecticut or located within the 48 states? The patients are located at residential addresses within the 48 states. 29. What are the standard requirements for the Dash Diet, as they can vary. A sodium-restricted Dietary Approaches to Stop Hypertension (DASH) eating pattern, which has been associated with lower heart failure (HF) incidence and greater survival in patients with HF. The DASH diet emphasizes heart-healthy foods, focusing on fruits, vegetables, whole grains, and low-fat dairy while limiting sodium, saturated fat, and added sugars. The following are required: Section B.3, p. 11, para 4. SCOPE.4.1.1 Study menu items must be restricted to meals in alignment with DASH Diet principles, at the discretion of the study team. The vendor must provide menu options that include: . Fruits . Vegetables . Whole grains . Lean protein options - chicken, turkey, fish, eggs, nuts, seeds, and/or legumes . Low-fat dairy products . Meals low in added sugars 30. Do you know the region/area the participants will be located? Shipping fees and amount of coolant vary wildly based on their proximity to our facility. The participants can be located anywhere within the 48 continental United States. The participants will be recruited throughout the period of performance. 31. We do not currently make/stock Halal foods. Is it possible another vendor can handle those meals or does 1 vendor need to do all of them? If that's the case, are you ok with us outsourcing to another meal provider? Yes, you are allowed to subcontract out as long as you meet the limitations of subcontracting. The limitations of subcontracting applies to the requirement. FAR Clause 52.219-14 establishes limitations on subcontracting for small business contractors, requiring them to perform a certain percentage of the contract work themselves to ensure they are not merely pass-through entities for larger firms. Small business contractors must perform at least 50% of the cost of contract performance incurred for personnel with their own employees. 32. It's difficult to anticipate the food costs 2-5 years in advance. Proteins particularly fluctuate month to month and year to year. If we were quoting this bid in 2020, I would NEVER have expected the food costs in 2025 to be so substantially higher than they were back then. Is there any part of the agreement that allows for a re-bib/ cost consideration if food costs rise so much? No there is not. This is a four year contract. Each year needs to be priced up front. You can add an increase in each year. The pricing will be evaluated by adding the total of all line-item prices for all four years. The Total Evaluated Price will be that sum. 33. Who is responsible for any damages to shipments, lost shipments, etc. Will the government pay for a new box for that participant. The contractor is responsible for re-delivery at no additional cost to the government. 34. Does working on a current clinical trial meet the requirement in Section 3.8: Vendor must have previously worked on clinical studies and trials or is completion of a trial necessary to qualify. Yes, this would qualify as experience previously worked on clinical studies and trials. 35. Can you consider extending the deadline for the response to quotes from 11/26/2025 to 12/03/2025? Yes the respond date is extended with this amendment from 11/26/2025 to 12/03/2025 at 3PM EST.

RFQ 36C24E26Q0002 Q&A LOG Geriatric Out-of-Hospital Meal Delivery Trial in Heart Failure Have any amendments or updates been made to the Statement of Work (SOW) since its initial release? No 2. Will the government be using specific performance metrics or KPIs to evaluate contractor success? In monthly reports, the study team will request at minimum: number of orders placed, number of orders fulfilled, number of delayed orders and reason for delay, customer service complaints and requests from study participants made to contractor, shipping time in days for orders fulfilled. 3. Is there a ceiling price, budget range, or estimated value associated with this contract? Yes, $1,500,000.00 for the total four years. 4. Should we include separate pricing for optional services or contingencies, such as veteran phone support or printed materials? No, this should be covered under the purchase of meals. 5. What is the anticipated award date and expected start of performance? January 2026 time frame. 6. Are there any critical milestones, phased deliverables, or onboarding timelines we should be aware of? No 7. Will there be flexibility in the delivery schedule in the event of unforeseen delays? No, the vendor shall deliver meals within 1-3 days (with exceptions of holidays, Sundays) from the date of order anywhere within the 48 continental United States with the capacity to ship up to 21 meals per week per patient. The meals need to meet study-specified nutritional requirements. Meals must be provided to cover a 42-day period, i.e., 6 weeks, for each of the 700 study participants, over a period of up to 48 months with the detailed time varying by participant s enrollment status. 8. Is there a small business subcontracting goal or requirement associated with this solicitation? The limitations of subcontracting applies to the requirement. FAR Clause 52.219-14 establishes limitations on subcontracting for small business contractors, requiring them to perform a certain percentage of the contract work themselves to ensure they are not merely pass-through entities for larger firms. Small business contractors must perform at least 50% of the cost of contract performance incurred for personnel with their own employees. 9. Are Letters of Commitment from subcontractors required at the time of proposal submission? No 10. Will the contractor be required to submit monthly or quarterly performance or compliance reports? If so, what format is preferred? The contractor must provide the study team with monthly reports of the orders fulfilled under the study-related account; email preferred. 11. Are there any mandatory training or certification requirements for personnel assigned to this contract? No 12. Will there be a Q&A period or pre-proposal conference scheduled prior to the submission deadline? The question period was to email questions to the Contracting Officer no later than 11/12/2025. Responses are due back through an amendment posted on or before 11/19/2025. 13. What is the expected response time after task order issuance for scheduled and unscheduled transports? The vendor shall deliver meals within 1-3 days (with exceptions of holidays, Sundays) from the date of order anywhere within the 48 continental United States with the capacity to ship up to 21 meals per week per patient. The meals need to meet study-specified nutritional requirements. Meals must be provided to cover a 42-day period, i.e., 6 weeks, for each of the 700 study participants, over a period of up to 48 months with the detailed time varying by participant s enrollment status. 14. Are there specific delivery windows or blackout periods (e.g., holidays, weekends) we should plan around? The vendor shall deliver meals within 1-3 days (with exceptions of holidays, Sundays) from the date of order anywhere within the 48 continental United States with the capacity to ship up to 21 meals per week per patient. The meals need to meet study-specified nutritional requirements. Meals must be provided to cover a 42-day period, i.e., 6 weeks, for each of the 700 study participants, over a period of up to 48 months with the detailed time varying by participant s enrollment status. 15. Will deliveries be required at multiple locations or centralized? Can the government provide a geographic breakdown of service areas? Deliveries will be required to multiple locations. Meals are required to be delivered to the participants home address Anywhere within the 48 continental United States. The service area is anywhere within the 48 continental United States depending on where each participant lives. 16. Is advance notice required before each transport or delivery? The VA study team must be able to track each delivery once it has been shipped. 17. Are there any specific packaging requirements, such as labeling, temperature control, or tamper-proof seals? Yes, Vendor personnel must be compliant with all applicable food safety laws and HIPPA regulations, Vendor must ensure food stability, safety, and quality maintenance during delivery process. 18. Should each transport or delivery include printed instructions or documentation? Yes 19. Is proof of delivery (POD) required for each transport? If so, what format is acceptable? Study team must receive proof of delivery for each transport. The acceptable format can include: tracking number of the shipment provided to the study team, delivery email directly to the study team, or study team access to the vendor s internal tracking system for the study participants. 20. Will the government require real-time tracking or delivery confirmation? Vendor must have a system to track the delivery once sent out for shipping and must have the ability to share this information with study team and study participants. Vendor must be able to provide a regular monthly report to the study team of orders fulfilled under study-related accounts. 21. Should delivery logs be submitted monthly, per task order, or in real time? Delivery logs must be submitted monthly. Vendor must be able to provide a regular monthly report to the study team of orders fulfilled under study-related accounts. 22. What is the protocol if transport is delayed or a vehicle is damaged? A replacement meal delivery will be sent to the participant as soon as possible at no cost to the government. 23. Will the contractor be responsible for re-delivery at no additional cost in such cases? Yes 24. Will transport be made to residential addresses, government facilities, or both? Residential addresses only. 25. Is there a preferred method for notifying the government of transport delays or service disruptions? Email notification as soon as the contractor becomes aware of the delay or disruption. 26. Will the contractor be required to provide customer service support to veterans or VA staff? Yes, both 27. When is the anticipated start date or contract period? January or February 2025 time frame. 28. Are the patients local to Connecticut or located within the 48 states? The patients are located at residential addresses within the 48 states. 29. What are the standard requirements for the Dash Diet, as they can vary. A sodium-restricted Dietary Approaches to Stop Hypertension (DASH) eating pattern, which has been associated with lower heart failure (HF) incidence and greater survival in patients with HF. The DASH diet emphasizes heart-healthy foods, focusing on fruits, vegetables, whole grains, and low-fat dairy while limiting sodium, saturated fat, and added sugars. The following are required: Section B.3, p. 11, para 4. SCOPE.4.1.1 Study menu items must be restricted to meals in alignment with DASH Diet principles, at the discretion of the study team. The vendor must provide menu options that include: . Fruits . Vegetables . Whole grains . Lean protein options - chicken, turkey, fish, eggs, nuts, seeds, and/or legumes . Low-fat dairy products . Meals low in added sugars 30. Do you know the region/area the participants will be located? Shipping fees and amount of coolant vary wildly based on their proximity to our facility. The participants can be located anywhere within the 48 continental United States. The participants will be recruited throughout the period of performance. 31. We do not currently make/stock Halal foods. Is it possible another vendor can handle those meals or does 1 vendor need to do all of them? If that's the case, are you ok with us outsourcing to another meal provider? Yes, you are allowed to subcontract out as long as you meet the limitations of subcontracting. The limitations of subcontracting applies to the requirement. FAR Clause 52.219-14 establishes limitations on subcontracting for small business contractors, requiring them to perform a certain percentage of the contract work themselves to ensure they are not merely pass-through entities for larger firms. Small business contractors must perform at least 50% of the cost of contract performance incurred for personnel with their own employees. 32. It's difficult to anticipate the food costs 2-5 years in advance. Proteins particularly fluctuate month to month and year to year. If we were quoting this bid in 2020, I would NEVER have expected the food costs in 2025 to be so substantially higher than they were back then. Is there any part of the agreement that allows for a re-bib/ cost consideration if food costs rise so much? No there is not. This is a four year contract. Each year needs to be priced up front. You can add an increase in each year. The pricing will be evaluated by adding the total of all line-item prices for all four years. The Total Evaluated Price will be that sum. 33. Who is responsible for any damages to shipments, lost shipments, etc. Will the government pay for a new box for that participant. The contractor is responsible for re-delivery at no additional cost to the government. 34. Does working on a current clinical trial meet the requirement in Section 3.8: Vendor must have previously worked on clinical studies and trials or is completion of a trial necessary to qualify. Yes, this would qualify as experience previously worked on clinical studies and trials. 35. Can you consider extending the deadline for the response to quotes from 11/26/2025 to 12/03/2025? Yes the respond date is extended with this amendment from 11/26/2025 to 12/03/2025 at 3PM EST.