36C24E26Q0002.docx

36C24E26Q0002

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1. REQUISITION

NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE

NO.

(No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

a.

THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

UEI:

EFT:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT:

REF.

___________________________________ OFFER

COPIES TO ISSUING OFFICE

CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________

YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

240E 36C24E26Q0002 11-05-2025 Ann Marie Stewart 401-919-0878 11/26/2025 15:00

EST

00240E Veterans Health Administration Regional Procurement Office East Building 32 Suite 1A1111 1010 Delafield Road Pittsburgh PA 15215-1802 X X 624210 $19.5 Million N/A X Veterans Health Administration West Haven VA Medical Center Research Office 950 Campbell Avenue West Haven CT 06516-2770 00240E Veterans Health Administration Regional Procurement Office East Building 32 Suite 1A1111 1010 Delafield Road Pittsburgh PA 15215-1802

00240E US Department of Veterans Affairs Financial Services Center (FSC) https://www.fsc.va.gov/einvoice.asp P.O. Box 149971 Austin TX 78714-8971 See CONTINUATION Page This is solicitation is for a home delivery meal service to ship nutritional restricted meals to Veterans homes shipping three (3) meals per day. The research study will enroll VA sites across the United States in accordance with Statement of Work, sec. B.

, pp.

The wage determination applies to this requirement and will based on the offeror’s location at time of award.

The contract resulting from this solicitation will be an Indefinite-Delivery Indefinite-Quantity type of contract.

The funds shall be obligated via individual Task Orders.

Please see Instructions to Offerors in Section E.1 and the Addendum to sec. E.1, pp. 4 -4 . Also see E.12 Evaluation- Commercial Products and Commercial Services, p. 5 -5 Please respond NLT 11/26/2025, 3

PM EDT by email only, to annmarie.stewart@va.gov.

$0.00 See CONTINUATION Page X X X Ann Marie Stewart

VA-VHA-2021-9A527CD0

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C24E Ann Marie Stewart Veterans Health Administration Regional Procurement Office East Building 32 Suite 1A1111 1010 Delafield Road Pittsburgh PA 15215-1802

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Financial Services Center (FSC) https://www.fsc.va.gov/einvoice.asp

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

This is an Indefinite Delivery Indefinite Quantity (IDIQ) firm fixed price contract in accordance with FAR 16.504. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract. The Schedule provides pricing for the items across the full four-year period of performance of this contract. There is no funding on this contract. Funding is placed on individual task orders issued against this contract. This solicitation is subject to the availability of funds.

The guaranteed contract minimum for the full four-year period of performance is 126 meals, and the maximum contract amount for the full four-year period of performance shall not exceed $1,500,000.00. The below estimated quantities will vary based on patient participation.

QUANTITY

Breakfast 7 breakfasts x 6 weeks = 42 x 200 participants = 8,400 Contract Period: Year 1 POP Begin: 01-01-2026 POP End: 12-31-2027 PRINCIPAL NAICS CODE: 624210 - Community Food Services PRODUCT/SERVICE CODE: S203 - Housekeeping - Food

Lunch 7 lunches x 6 weeks = 42 x 200 participants = 8,400 Contract Period: Year 1 POP Begin: 01-01-2026 POP End: 12-31-2027

Dinner 7 dinners x 6 weeks = 42 x 200 participants = 8,400 Contract Period: Year 1 POP Begin: 01-01-2026 POP End: 12-31-2027

Halal/Kosher meal breakfast 7 dinners x 6 weeks = 42 x 3 participants = 126 Contract Period: Year 1 POP Begin: 01-01-2026 POP End: 12-31-2027

126.00

EA

Halal/Kosher meal lunch 7 lunch x 6 weeks = 42 x 3 participants = 126 Contract Period: Year 1 POP Begin: 01-01-2026 POP End: 12-31-2027

Halal/Kosher meal dinner 7 dinners x 6 weeks = 42 x 3 participants = 126 Contract Period: Year 1 POP Begin: 01-01-2026 POP End: 12-31-2027

Delivery 203 patients for 6 weeks each 203 x 6 = 1,218 weeks per year Contract Period: Year 1 POP Begin: 01-01-2026 POP End: 12-31-2027

Breakfast

Contract Period: Year 2 POP Begin: 01-01-2027 POP End: 12-31-2028

Lunch

Contract Period: Year 2 POP Begin: 01-01-2027 POP End: 12-31-2028

Dinner 7 dinners x 6 weeks = 42 x 200 participants = 8,400 Contract Period: Year 2 POP Begin: 01-01-2027 POP End: 12-31-2028

Halal/Kosher meal breakfast 7 breakfast x 6 weeks = 42 x 3 participants = 126 Contract Period: Year 2 POP Begin: 01-01-2027 POP End: 12-31-2028

Halal/Kosher meal lunch

Contract Period: Year 2 POP Begin: 01-01-2027 POP End: 12-31-2028

Halal/Kosher meal dinner 7 dinner x 6 weeks = 42 x 3 participants = 126 Contract Period: Year 2 POP Begin: 01-01-2027 POP End: 12-31-2028

Delivery

203 x 6 = 1,218 weeks per year Contract Period: Year 2 POP Begin: 01-01-2027 POP End: 12-31-2028

Breakfast

Contract Period: Year 3 POP Begin: 01-01-2028 POP End: 12-31-2029

Lunch

Contract Period: Year 3 POP Begin: 01-01-2028 POP End: 12-31-2029

Dinner 7 Dinners x 6 weeks = 42 x 200 participants = 8,400 Contract Period: Year 3 POP Begin: 01-01-2028 POP End: 12-31-2029

Halal/Kosher meal breakfast 7 breakfast x 6 weeks = 42 x 3 participants = 126 Contract Period: Year 3 POP Begin: 01-01-2028 POP End: 12-31-2029

Halal/Kosher meal lunch

Contract Period: Year 3 POP Begin: 01-01-2028 POP End: 12-31-2029

Halal/Kosher meal dinner 7 dinner x 6 weeks = 42 x 3 participants = 126 Contract Period: Year 3 POP Begin: 01-01-2028 POP End: 12-31-2029

Delivery

203 x 6 = 1,218 weeks per year Contract Period: Year 3 POP Begin: 01-01-2028 POP End: 12-31-2029

4,200.00

EA

Breakfast 7 breakfasts x 6 weeks = 42 x 100 participants = 4.200 Contract Period: Year 4 POP Begin: 01-01-2029 POP End: 12-31-2030

Lunch 7 lunches x 6 weeks = 42 x 100 participants =4.200 Contract Period: Year 4 POP Begin: 01-01-2029 POP End: 12-31-2030

Dinner 7 dinners x 6 weeks = 42 x 100 participants = 4.200 Contract Period: Year 4 POP Begin: 01-01-2029 POP End: 12-31-2030

Halal/Kosher meal breakfast 7 breakfast x 6 weeks = 42 x 2 participants = 84 Contract Period: Year 4 POP Begin: 01-01-2029 POP End: 12-31-2030

Halal/Kosher meal lunch 7 lunch x 6 weeks = 42 x 2 participants = 84 Contract Period: Year 4 POP Begin: 01-01-2029 POP End: 12-31-2030

Halal/Kosher meal dinner 7 dinner x 6 weeks = 42 x 2 participants = 84 Contract Period: Year 4 POP Begin: 01-01-2029 POP End: 12-31-2030

Delivery 102 patients for 6 weeks each 102 x 6 = 612 weeks per year Contract Period: Year 4 POP Begin: 01-01-2029 POP End: 12-31-2030

GRAND TOTAL

Page 1 of

B.3 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 by the VA. Intervention arm participants (n=700) will receive home-delivered meals for a period of 6 weeks post-discharge and the VA will provide a total of three remotely delivered dietary counseling sessions.

This study will enroll 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. The exclusion criteria include food allergies or intolerances that cannot be accommodated by study diet; on dialysis or estimated glomerular filtration rate <30 at randomization; serum potassium (non-hemolyzed) >6.0 mmol/L during index hospitalization; heart transplant or active transplant listing; left ventricular assist device present or anticipated <6 months; malignancy or other non-cardiac condition limiting life expectancy to <12 months; planned admission to a skilled nursing facility following hospital discharge, or discharge to other location/situation where participant does not have control over diet; lack of space to store food for a week or equipment to prepare food; severe cognitive impairment; body mass index >50 kg/m2. Inclusion and exclusion criteria are designed to enroll a broad representative cohort of Veterans with HF.

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 vendor 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 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.

The meal vendor must meet the following:

3.1 Vendor personnel must be compliant with all applicable food safety laws and HIPPA regulations.

3.2 Vendor must have minimum of 3 years’ experience of demonstrated ability to deliver high quality meals within all 48 continental United States.

3.3 Vendor must ensure food stability, safety, and quality maintenance during delivery process.

3.4 Vendor must provide meals that meet study-specified nutritional requirements (refer to Section 4.1).

3.5 Vendor must provide a way of ordering meals that meet study requirements (refer to Section 4.2).

3.6 Vendor must meet VA regulations on the transfer and storage of personally identifying information (refer to Section 4.4).

3.7 Vendor must meet study team specified reporting requirements (refer to Section 4.4).

3.8 Vendor must have previously worked on clinical studies and trials.

4. TASKS.

4.1 Meal and Meal Instructions: Potential contracting vendors responding to this Solicitation must demonstrate a thorough understanding and have significant experience in the practice of food preparation and delivery.

The following are required:

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

4.1.2 Study participants can only order meal items from a study menu approved by the VA study team

4.1.3 Vendor must send study team their menu lists with nutrition facts as part of bidding process

4.1.4 Vendor must provide a menu that can accommodate participants’ dietary needs, to be determined by study team based on participants’ body size and medical status.

4.1.5 A modifiable energy intake range from 1,500 – 2,600 kcal per day

4.1.6 A modifiable sodium range of 1,500 - 3,000 mg Na per day

4.1.7 A modifiable potassium range of 2,000 – 4,500 mg K per day

4.1.8 If the current menus provided by the meal vendor do not meet DASH diet principles (see item 4.1.1), the meal vendor must work with study team to create study-specific menus to meet nutritional targets within 1 month of request.

4.1.9 Meals must be pre-prepared, with ability to re-heat food items via microwave (preferred) and/or in oven. Meal preparation for the participant should be < 5 to 7 minutes.

4.1.10 Menu must include Breakfast, Lunch, and Dinner entrees.

4.1.11 Vendor must provide at least 7 vegan/vegetarian entrees with at least 2 options available for each of breakfast, lunch, and dinner.

4.1.12 Vendor must accommodate special dietary modifications, such as Kosher, Halal, gluten-free, vegan, or a soft diet.

4.1.13 Vendor must accommodate special diets, including:

· Diabetes friendly/carbohydrate-controlled meal options

· Renal diet

4.1.14 At the instruction of the study team, vendor must have the ability to modify a participant’s dietary plan as needed (e.g., transition to lower potassium content if kidney function worsens).

4.1.15 Vendor must ensure that majority of meals are prepared and packaged from their company space, unless for special food considerations (see item 4.1.12).

4.1.16 Vendor must disclose if they outsource meals and provide information as to where meals are coming from.

4.1.17 Vendor must provide clear meal preparation instructions with each delivery to maximize meal quality and safety, with willingness to adapt these for participant characteristics (e.g., visual impairment, reading level).

4.1.18 Vendor must provide clear storage instructions with each delivery to maintain food safety and quality in participant’s home (e.g., refrigerate ≥ 7 days, freeze up to 3 months).

4.1.19 Vendor must provide supplemental food items (snack items, produce boxes) if nutritional targets (i.e. calorie goals) cannot be met with 3 meals per day alone.

4.1.20 Vendor must update the study team if changes are made to menu items.

4.2 Meal Menu and Ordering Characteristics:

The following are required:

4.2.1 Vendor must have the ability to prevent a participant from ordering or receiving items outside of their assigned menu (i.e. high potassium food options restricted for the participants requiring a low potassium menu).

4.2.2 Vendor must have process in place to prevent a participant from ordering or receiving food with their listed allergens or foods that should be avoided.

4.2.3 Vendor must provide an online menu and must provide a printed menu to participants who do not have internet access.

4.2.4 Vendor must provide telephone-based customer service for placing orders for participants who are unable to use internet-based ordering methods.

4.2.5 Vendor must have an ordering system that will automatically select and ship participant meals if a participant forgets to select their weekly meals, or if the participant does not want to select their meals. The automatically selected meals must fit within the participant’s specific nutrition and safety requirements.

4.3 Distribution and Other Logistics:

The following are required:

4.3.1 Vendor must have the ability to deliver meals within 3 days on deliverable days (with exceptions of holidays, Sundays) from the date of order anywhere within the 48 continental United States.

4.3.1.1.1 Vendor must notify the study team within 24 hours if a delivery cannot be filled within this timeframe.

4.3.2 Vendor must have the capacity to ship 21 meals per week in one delivery.

4.3.3 Vendor must not require signature upon delivery.

4.3.4 Vendors must be willing to resend the meals in case of failure of delivery, damaged food items upon delivery, or food safety concerns at no additional cost to the study.

4.3.5 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 (see bullet 4.4.3).

4.3.6 Vendor should provide telephone-based and online customer service for participants to notify the meal vendor of problems, concerns or to share participant experiences.

4.3.7 Vendor must assign all costs to the research study, with no cost or billing to participants.

4.3.8 Vendor should identify a primary contact person and a backup contact person to work with study team to resolve issues.

4.3.9 Vendors must meet with study team regularly (monthly) to discuss ongoing updates and work through issues that arise.

4.3.10 Vendor must have ability to share ingredient list and nutrition facts labels with the study team for all food items provided, including any items sourced from other vendors or subcontractors.

4.4 Reporting and Security Requirements:

Meal vendor must meet the following:

4.4.1 Vendor must follow all applicable VA regulations, such as encrypted email, 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.

4.4.2 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.

4.4.3 Vendor must be able to provide a regular monthly report to the study team of orders fulfilled under study-related accounts.

4.4.4 Vendor must provide an alert to the study team within 72 hours if participants discontinue meal orders.

4.4.5 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.

4.4.6 Vendor must provide VA with a process for the participant and/or site study coordinator to report food safety concerns to the meal vendor, such as food poisoning report after food consumption.

4.4.7 Vendor must track and provide study team with information about participant-initiated contact with the meal vendor. At a minimum, the meal vendor must track and provide: the date the participant contacted the meal vendor; the VA site that the participant is affiliated with; the reason the participant contacted the vendor; and, if the reason related to a problem, how the problem was addressed or resolved.

5. PLACE OF PERFORMANCE

The place of performance will take place at the Contractor’s place of business.

6. GOVERNMENT-FURNISHED EQUIPMENT

There will be no government-furnished equipment provided.

7. IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor's employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor's information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA's information is returned to the VA or destroyed in accordance with VA's sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/ subcontractor must not destroy information received from VA, or gathered/ created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor's firewall and Web services security controls, if applicable, shall meet or exceed VA's minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA's prior written approval. The contractor/subcontractor must refer all requests for demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

b. The contractor/subcontractor shall certify to the COR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.

c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default "program files" directory and silently install and uninstall.

d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.

e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.

f. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.

g. The contractor/subcontractor agrees to:

(1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:

(a) The Systems of Records (SOR); and

(b) The design, development, or operation work that the contractor/ subcontractor is to perform;

(1) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and

(2) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR.

h. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency.

(1) "Operation of a System of Records" means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.

(2) "Record" means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person's name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.

(3) "System of Records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

i. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as "Systems"), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than 10 days.

k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within 5 days.

l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.

5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerablity scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor's security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA's network involving VA information must be reviewed and approved by VA prior to implementation.

b. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.

c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor's systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government- owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

d. The contractor/subcontractor's system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA's POA&M management process. The contractor/subcontractor must use VA's POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/ subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re- authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

e. The contractor/subcontractor must conduct an annual self assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

f. VA prohibits the installation and use of personally-owned or contractor/ subcontractor-owned equipment or software on VA's network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA-approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.

g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/ subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.

h. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:

(1) Vendor must accept the system without the drive;

(2) VA's initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

(3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

(4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

(a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and

(b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract.

(c) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.

6. SECURITY INCIDENT INVESTIGATION

a. The term "security incident" means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/ subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/ subcontractor has access.

b. To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident.