SOURCES SOUGHT NOTICE Sources Sought: This is NOT a solicitation for a proposal, proposal abstract, or quote. The purpose of this notice is to obtain information regarding qualified business sources. The responses to the information requested will assist the Government in determining the appropriate acquisition method. STATEMENT OF WORK (SOW) 1. CONTRACT TITLE. Meal Vendor, CSP 2025 Geriatric Out-of-hospital Randomized Meal Trial in heart failure: Veterans Affairs (GOURMET-VA) 2. BACKGROUND. 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 in addition to the study-defined standard of care (standardized dietary education and a single dietary counseling session shortly after discharge) compared to the study-defined standard of care alone. The study-provided meals and dietary education/counseling 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. All participants will receive VA-approved dietary educational material at enrollment, and a single, remotely delivered dietary counseling session during the first week post-discharge. Intervention arm participants will receive home-delivered meals for a period of 6 weeks post-discharge and a total of three remotely delivered dietary counseling sessions. This study will enroll 1,400 Veteran participants aged 60 years who have been hospitalized ( 24 hours) for new HF or worsening chronic HF at a Veterans Affairs medical facility. Eligible participants need to have dentition, swallowing function, etc. sufficient to safely consume food and liquid of standard composition and texture (pureed meals may be allowable). The exclusion criteria include food allergies or intolerances that cannot be accommodated by study diet; on dialysis or estimated glomerular filtration rate 6.0 mmol/L during index hospitalization; heart transplant or active transplant listing; left ventricular assist device present or anticipated 50 kg/m2. Inclusion and exclusion criteria are designed to enroll a broadly representative cohort of Veterans with HF. The study will enroll at 35-40 VA sites across the United States a 3-year period, with the expectation of around 1 patient per site per month that is randomized to the intervention arm. Participants will be screened and consented during the index hospitalization and randomized at or near the expected date of discharge. For those who are randomized to the intervention arm, the study coordinator will communicate with meal vendors regarding the recommended dietary specifications based on the participant s health conditions. The Study coordinator will provide education to the participant on meal selection guidelines and delivery times. 3. SCOPE. 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 (and Puerto Rico is desired) with the capacity to ship up to 21 meals per week. The meals need to meet study-specified nutritional requirements. The anticipated need is for meals to cover a 42-day period , i.e., 6 weeks, for each of the 720 study participants, over a period of about 24 months with the detailed time varying by participant s enrollment status. Meal vendor personnel shall be compliant with all applicable laws and regulations. Meal vendor shall have minimum of 3 years experience of demonstrated ability to deliver high quality meals within all 48 continental United States. Meal vendor must ensure food stability, safety, and quality maintenance during delivery process. Meal vendor must provide meals that meet study-specified nutritional requirements. (refer to Section 4.1) Meal vendor must provide ways of meal ordering that meet study requirements. (refer to Section 4.2) Meal vendor must meet VA regulations on the transfer and storage of personally identifying information. (refer to Section 4.4) Meal vendor must study team specified reporting requirements. 4. SALIENT CHARACTERISTICS/TASKS. Meal and Meal Instructions Characteristics: Menu must be aligned with DASH Diet principles: Minimum of 3 fruit servings per day Minimum of 3 vegetable servings per day Desired to provide at least 50% of grains as whole grains. 50% of delivered meals should meet lean protein options - chicken, turkey, fish, eggs, nuts, seeds, legumes. Meals delivered should include low-fat dairy products any range/max/min amounts? Menu must be able to accommodate participants dietary need, to be determined by study team based on participants body size and medical status. energy intakes range from 1,500 2,600 kcal per day. a modifiable sodium range of 1,500 - 3,000 mg Na per day a modifiable potassium range of 2,000 4,500 mg K per day Meals must be pre-prepared, with ability to re-heat food items via microwave (preferred) and/or in oven. Meal preparation for the participant is desired to be < 5 minutes. If meals alone are unable to meet nutritional targets, meal vendor must provide supplemental food items to meet nutrition goals (e.g., snack box, produce items) Menu must contain Breakfast, Lunch, and Dinner entrees. Meal options should have at least 7 vegan/vegetarian entrees with at least 2 options available for each of breakfast, lunch, and dinner. Meal can accommodate special diets, including: Diabetes friendly/carbohydrate-controlled meal options Gluten free options It is desirable to accommodate Kosher and Halal dietary modifications. It is desirable to offer options suitable for individuals with difficulty chewing/swallowing (e.g., pureed meals) Study team will have the ability to modify dietary plan as needed (e.g., transition to lower potassium content if kidney function worsens). It is desirable that meal vendor work with study team to create study-specific menus, and meal vendor shall update study team if changes need to be made to menu items. Meal vendor must ensure that majority of meals are prepared and packaged from their company space, unless for special food considerations such as Halal or Kosher. Meal vendor must disclose if they outsource meals and provide information as to where meals are coming from. Meal vendor must provide clear meal preparation instructions to maximize meal quality and safety, with willingness to adapt these for participant characteristics (e.g., visual impairment, reading level). Meal vendor must provide clear storage instructions to maintain food safety and quality in participant s home (e.g., refrigerate 7 days, freeze up to 3 months). Meal Menu and Ordering Characteristics: Meal vendor should work with study team to limit/allow designated menu items to each participant depending on their specific nutrition requirements (e.g., low potassium vs high potassium). Participants must not be able to order items outside of their assigned menu. Meal vendor shall provide an online menu and provide a printed menu to participants who do not have internet access. Meal vendor must have process in place to avoid participant ordering/receiving foods with their listed allergens or food preferences. Meal vendor shall provide telephone-based customer service for placing orders if participant is unable to use internet-based ordering methods. It is desirable to have capacity to serve Spanish-speaking and hard-of-hearing individuals. The meal vendor must have an ordering system that will automatically select and ship participant meals if a participant forgets to select their meals, or if the participant does not want to select their meals. The automatically selected meals must fit within the participant s specific nutrition requirements. It is desired for the study team to have access to a participant portal Distribution and Other Logistics: Meal 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. Delivery to Puerto Rico is desired. Meal vendor shall have the capacity to ship up to 21 meals per week. Meal vendor must be flexible on delivery timing and will not require signature upon delivery. Meal vendors must be willing to resend the meals in case of failure of delivery, or damaged food items upon delivery. Meal vendor must have a system to track the delivery once sent out for shipping and ability to share this information with study team and study participants (see bullet 4.4.4). Meal vendor should provide telephone-based and online customer service for participants to notify the meal vendor of problems, concerns or to share participant experiences. Meal vendor shall assign all costs to the research study, with no cost or billing to participants. Meal vendor should identify a primary contact person and a backup contact person to work with study team to resolve issues. Meal vendors must be willing to virtually meet with study team regularly (monthly) to discuss ongoing updates and work through issues that arise. Meal vendor must have ability to share ingredient list and nutrition facts label with the study team for all food items provided, including any items sourced from other vendors or subcontractors. Reporting and Security Requirements: Meal vendor must follow all applicable VA regulations on the transfer and storage of personally identifying information (PII) of participants, e.g. name, address, and email/telephone number required for food ordering and delivery. Study participants will each be assigned a study number, e.g. xx (study site)-yyy (participant number). Communications between the meal vendor and study team and reports (see below) must not contain PII, but rather should be identified/categorized using participants study numbers. Meal vendor must notify study team within 72 hours of knowledge of any suspected or identified data breach which could result in unauthorized access or other compromise of participants PII. Meal vendor must be able to provide a report to the study team of orders fulfilled under study-related accounts, desired to be weekly and automated. Meal vendor should provide an automated alert to the study team within 72 hours if participants discontinue meal orders. Meal vendor should provide an automated alert to the study within 72 hours if they are unsuccessful with reaching participant and have been unable to fill food order. Meal vendor must alert participants and the study team within 24 hours of knowledge of issues that could cause food safety concerns, including but not limited to food delivery delay causing food to be unsafe for consumption, or if meal order contains recalled food items. Meal vendor shall provide VA a process for the participant and/or site study coordinator to report food safety concerns, such as food poisoning report after food consumption. Meal vendor should categorize and quantify participant feedback and share it with the study team. 5. SUMMARY: This is a Sources Sought notice and not a request for quotes. This request is solely for the purpose of conducting market research to enhance VHA s understanding of the market s offered products, services, and capabilities. The Government will not pay any costs for responses submitted in response to this Sources Sought. This Sources Sought notice provides an opportunity for respondents to submit their notice of ability, and their available products and services in response to the requirement. Vendors are being invited to submit information relative to their potential of fulfilling this requirement in the form of a capability response that addresses the specific requirement identified in this Sources Sought. This Sources Sought is to facilitate the Contracting Officer s review of the market base, for acquisition planning, size determination, and procurement strategy. 6. RESPONSE COMMITMENT 6.1. Response: A. Capability statement with general understanding of the industry and current knowledge and subcontract networks that would be used to support the requirement as identified herein. Information should suggest, NACIS Code, provide the socioeconomic status for your company and your subcontractors if you are planning on supporting this service with subcontractors. Submittals furnished will not be returned to the sender. No debriefs will be conducted. Eligibility in participating in a future acquisition does not depend upon a response to this notice. The capability statement must show clear detailed qualifications that will meet this requirement. Please provide your companies business status: Large, Small, VOSB, or an SDVOSB. Please include your company s SAM.gov Unique Entity ID (UEI) number. B. Request for Information (RFI): Reaching out to industry to offer suggestions on how to structure line items for pricing purposes. Please do not provide pricing. We are just looking for different ideas on ways to develop the line-item structure for pricing meals. C. Proprietary information is neither requested nor desired. If such information is submitted, it must clearly be marked "proprietary" on every sheet containing such information, and the proprietary information must be segregated to the maximum extent practicable from other portions of the response (e.g., use an attachment or exhibit). D. Submit responses by email only to
[email protected] 6.2. Timeline: A. This request will close on stated date within the Government Point of Entry (GPE). 6.3 Notes: 1. This Sources Sought is for planning purposes only, and does not constitute a commitment, implied or otherwise that a procurement action will follow. The Department of Veterans Affairs will use the information submitted in response to this notice at its discretion and will not provide comments to any submission; however, the Department of Veterans Affairs reserves the right to contact any respondent to this notice for the sole purpose of enhancing the Department of Veteran Affairs understanding of the notice submission. 2. The content of any responses to this notice may be reflected in any subsequent solicitation, except for content marked or designated as business confidential or proprietary which will be fully protected from release outside the government. The Department of Veteran Affairs Contracting Office POC: Ann Marie Stewart Contracting Officer
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