36C26326Q0492.pdf

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J065--Bayer Contrast Injectors Maintenance
Solicitation number
36C26326Q0492
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This is a Solicitation/Contract/Order for Commercial Products and Commercial Services (Standard Form 1449) issued by the Department of Veterans Affairs for Bayer/Medrad equipment maintenance services.

The solicitation seeks a single-award Indefinite Delivery Indefinite Quantity (IDIQ) contract for predictive maintenance and related services on Bayer/Medrad contrast injectors at VA VISN 23 medical facilities located in Iowa, Nebraska, Minnesota, North Dakota, and South Dakota. The contract period consists of three one-year ordering periods from the date of award. The Government has set a maximum contract value of $1,100,000.00 with a guaranteed minimum of $25,000.00. This is a 100% Service-Disabled Veteran-Owned Small Business (SDVOSB) set-aside under NAICS code 811210 with a size standard of $34 million. The solicitation number is 36C26326Q0492, issued April 8, 2026, with an offer due date of April 16, 2026, at 4:00 PM CST. Evaluation will be based on technical capability (vendor qualifications and PWS satisfaction), past performance, and price, with technical and past performance weighted more heavily than price. Monthly invoicing is required, submitted electronically through VA's designated system or X12 EDI formats. The Government reserves the right to award without discussions and may reject any or all offers. Offerors must provide proof of OEM factory-certified training, authorization letters from the equipment manufacturer, and demonstrate field service representative availability within five hours of each VISN 23 medical center. All parts used must be OEM-only, with reverse-engineered or refurbished parts prohibited without written contracting officer approval. Subcontracting is not permitted without written contracting officer authorization.

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D.2 Quality Assurance Surveillance Plan -QASP- Contrast Injectors.pdf PDF
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PAGE 1 OF 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

13a. 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

N/A

36C26326Q0492 04/08/2026

Jennifer Watkins-Schoenig 319-688-3631 04/16/2026

4:00 PM CST

36C263

DEPARTMENT OF VETERANS AFFAIRS

NETWORK CONTRACTING OFFICE 23

1303 5TH STREET, SUITE 300

CORALVILLE IA 52241

X 100

X

811210

$34 Million

N/A

DEPARTMENT OF VETERANS AFFAIRS

VISN 23- Multiple Sites See Sections B.2 and B.3 for details

NETWORK CONTRACTING OFFICE 23

1303 5TH STREET, SUITE 300

CORALVILLE IA 52241

FMS-VA-2(101)

FINANCIAL SERVICES CENTER

PO BOX 149971

AUSTIN TX 78714-9971

See CONTINUATION Page

Single award IDIQ for Bayer Contrast Injectors Maintenance services at VISN 23 sites.

See Section B.2 for Performance Work Statement (PWS)

See Section B.3 for Schedule of Services Total SDVOSB Set Aside

Comparative Evaluation, see provision 52.212-2 for items required to be submitted with proposals.

FOR CONSIDERATION, ALL QUESTIONS MUST BE RECEIVED 72 HOURS

BEFORE DATE STIPULATED IN BLOCK 8 OF THE SF1449 FORM. EMAIL

QUESTIONS AND RESPONSES TO: JENNIFER.WATKINS-SCHOENIG@VA.GOV

AND JOSHUA.IMDACHA@VA.GOV

SIGN SF1449 AND RETURN ALL PAGES WITH OFFER SUBMISSION.

SEE PROVISION 52.212-1 AND ADDENDUM TO 52.212-1 FOR ITEMS

REQUIRED TO BE SUBMITTED WITH PROPOSALS.

See CONTINUATION Page

To be funded by task orders

X X

X 1

Joshua Imdacha Contracting Officer

36C26326Q0492

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PERFORMANCE WORK STATEMENT

B.3 PRICE/COST SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 TERMS AND CONDITIONS- COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (NOV 2023) (DEVIATION OCT 2025)

C.2 52.216-18 ORDERING (AUG 2020)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.4 52.216-22 INDEFINITE QUANTITY (NOV 2025) (DEVIATION)

C.5 52.219-14 LIMITATIONS ON SUBCONTRACTING (NOV 2025) (DEVIATION)

C.6 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR

1984)

C.7 52.240-91 SECURITY PROHIBITIONS AND EXCLUSIONS (NOV 2025)

(DEVIATION)

C.8 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.9 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

C.10 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.11 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED

SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESSES (JAN 2023)

(DEVIATION)

C.12 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023)

(DEVIATION)

C.13 VAAR 852.222-71 COMPLIANCE WITH EXECUTIVE ORDER 13899

(DEVIATION)(APR 2025)

C.14 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

C.15 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ..51

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 PRICE SCHEDULE

D.2 Quality Assurance Surveillance Plan -QASP- Contrast Injectors

SECTION E - SOLICITATION PROVISIONS

E.1 52.201-1 ACQUISITION 360: VOLUNTARY SURVEY (SEP 2023)

E.2 52.212-1 INSTRUCTIONS TO OFFERORS – COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023) (DEVIATION OCT 2025)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.4 52.216-1 TYPE OF CONTRACT (NOV 2025) (DEVIATION)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 52.240-90 SECURITY PROHIBITIONS AND EXCLUSIONS REPRESENTATIONS

AND CERTIFICATIONS (NOV 2025) (DEVIATION)

E.7 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.8 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

E.9 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.10 52.212-2 EVALUATION- COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021) (DEVIATION OCT 2025)

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 36C263

NETWORK CONTRACTING OFFICE 23

1303 5TH STREET, SUITE 300

CORALVILLE IA 52241

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly

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.

http://www.tungsten-network.com/

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

AMENDMENT NO DATE

B.2 PERFORMANCE WORK STATEMENT

BAYER/MEDRAD EQUIPMENT SERVICE CONTRACT

1. SCOPE: Contractor shall furnish all labor, transportation, parts, and expertise necessary to provide predictive maintenance (PM) of various Bayer/ Medrad™ equipment at VISN 23 facilities listed below in accordance with the attached equipment list (see below).

2. CONTRACT PERIOD: Contract period shall be 3, 1 year ordering periods from date of award.

3. QUALIFICATIONS: To be considered eligible for consideration, bidders must have a field service representative located within 5 hours of each medical center located in VISN 23 (i.e.

Iowa, Nebraska, Minnesota, North Dakota and South Dakota) that has been trained by the Original Equipment Manufacturer (OEM) on the specific model of equipment he/she is being asked to work on. Bidders must provide, upon request, documentation of factory-certified service/maintenance training on the specific equipment under the terms of this contract. All parts used shall be OEM parts only. Reverse engineered and/or refurbished parts shall not be utilized under the terms of this contract without explicit permission, in writing, from the Contracting Officer. Subcontracting of any ensuing award of this solicitation will not be allowed without written permission of the Contracting Officer.

4. SERVICES TO BE PROVIDED:

A. General:

1) Contractor will provide the necessary manpower and supervision to properly execute the Periodic maintenance of the equipment listed below.

2) A “Field Service Report” (FSR) must be generated and a copy given to respective VISN 23 Biomedical Engineering point of contact at each facility listed below or designee after each episode of scheduled maintenance.

B. Predictive Maintenance:

1) Predictive Maintenance will be performed by the contractor at the intervals that are in accordance with the manufacturer’s recommendations, but no less than annually.

2) Contractor will furnish any required “PM kits” (parts, test equipment, software, and/or supplies) needed to perform Predictive Maintenance.

C. Certegra Software:

1) Contractor will provide updates to the Certegra software on the injectors listed in below as “Stellent-C”

2) Contractor will provide diagnose and handle reported errors with the Certegra software

3) Contractor will provide services of a qualified representative of Bayer to correct any non-conformance of the Certegra software

4) Contractor will provide customer telephone support for the Certegra software

D. TechCare Basic on the Stellant D CT Injection Systems

E. Documentation: A documentation package acceptable for Joint Commission purposes will be maintained by the contractor and made available to each medical center in VISN

23. Required features include, at a minimum:

1) Serial Number of equipment serviced

2) Any and all work performed on a particular date

3) Predictive Maintenance – The contractor will perform PM according to manufacturer’s specifications. The contractor will have written procedures to be followed and documented evidence that each piece of equipment has been inspected according to those procedures.

F. New Equipment: Equipment may be added or deleted from the service contract as needed upon notification by the Contracting Officer (to be documented in writing via contract amendment). Deleted equipment will be credited in the full amount if deleted before any scheduled maintenance has been performed on it.

5. SPECIAL INSTRUCTIONS:

A. Contractor Check-In: The contractor’s representative will contact Facilities point of contact as listed below, to schedule and check-in prior to performing predictive maintenance services at the respective facilities.

B. Documentation: At the conclusion of each scheduled maintenance visit, the contractor will provide a written service report indicating the date of service, the model, serial number, and location of equipment serviced; the name of the representative, and the services performed and parts replaced. The reports will be delivered to Biomedical Engineering.

C. User Responsibility: The contractor will not be held responsible under the terms of this contract for repairs to equipment necessitated by user abuse and/or misuse of equipment.

D. Exclusions: Service does not include electrical work external to the equipment. The articulating arm for each contrast injector in equipment listing below, is not to be included; the maintenance of the arms will be handled by in-house Biomedical Engineering staff.

6. ACCEPTABLE QUALITY LEVELS

A. The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

Performance Objective

SOW Paragraph Performance Standard

Acceptable Quality Levels

Predictive Maintenance

4B Predictive Maintenance will be performed by the contractor at the intervals that are in accordance with the manufacturer’s recommendations, but no less than annually

100% compliance to standards, unless otherwise noted

Certegra Software 4C Provide software updates and telephone technical support

Response to telephone tech support during regular business hours with 2 hours, onsite response (if needed) within 24 hours

Documentation 5B Provide thorough documentation of work performed, including serial number of device worked on, problem identified, and remedy applied.

Provide within 30 days of completion or upon request during audits or external reviews.

List of Contrast Injectors

VISN 23 Facility Type of Injector Serial Number

Fargo Mark 7 Arterion 300053 Fargo Stellant Flex 200752U1 Fargo Stellant Flex 200780U1 Fargo MRXperion 310241 Iowa City Mark 7 Arterion 201497 Iowa City Mark 7 Arterion 312896 Iowa City Advanta 10198 Iowa City Stellant Flex 120133 Iowa City Stellant Flex 200881U1 Iowa City Stellant Flex 204167U1 Iowa City Stellant Flex 300931U1 Iowa City Stellant Flex 203676U1 Iowa City MRXperion 300491 Iowa City MRXperion 300492 Minneapolis Mark 7 Arterion 201464 Minneapolis Mark 7 Arterion 201917 Minneapolis Mark 7 Arterion 300163 Minneapolis Mark 7 Arterion 300540 Minneapolis Mark 7 Arterion 300617 Minneapolis Mark 7 Arterion 301414 Minneapolis Stellant Flex 204510U1 Minneapolis Stellant Flex 41230U1 Minneapolis Stellant Flex 101332 Minneapolis Stellant Flex 202318U1 Minneapolis MRXperion 311734 Minneapolis Spectris Solaris 100846 NWI – Omaha Mark 7 Arterion 105074 NWI – Omaha Mark 7 Arterion 200591 NWI – Omaha Stellant Flex 121647 NWI – Omaha Stellant Flex 201356U1 NWI – Omaha Stellant Flex 201361U1 NWI – Omaha Stellant Flex 204266U1 NWI – Omaha Stellant Flex 34571U1 NWI – Omaha Intego 100104 NWI – Omaha MRXperion 310512 NWI – Omaha MRXperion 310518 NWI – Grand Island Stellant Flex 201041U1

NWI – Lincoln Stellant Flex 201100U1 Central Iowa Mark 7 Arterion 200444 Central Iowa Stellant Flex 203594U1 Central Iowa Stellant Flex 100423U1 Central Iowa Stellant Flex 203591U1 Central Iowa Stellant Flex 100439 Central Iowa Intego 30128U1 Central Iowa MRXperion 314154 Sioux Falls Stellant Flex 203568U1 Sioux Falls Stellant Flex 300846U1 Sioux Falls MRXperion 310273 St. Cloud Stellant Flex 202586U1 St. Cloud MRXperion 314183 Black Hills Stellant Flex 100546U1 Black Hills Stellant Flex 201364U1 Black Hills MRXperion 300803 Black Hills MRXperion 310280

Facility and Point of Contact list for VISN 23 (full point of contact list will be provided upon award)

Facility Address Point of Contact Phone Number

Des Moines Division - VA Central Iowa Health Care System

3600 30th Street Des Moines, IA 50310

Iowa City VA Medical Center 601 Highway 6 West Iowa City, IA 52246-

Fargo VA Medical Center 2101 Elm Street Fargo, ND 58102

Minneapolis VA Medical Center One Veterans Drive

Minneapolis, MN 55417

Omaha Division - VA Nebraska Western Iowa Health Care

System

4101 Woolworth Ave.

Omaha, NE 68105

Lincoln Division - VA Nebraska Western Iowa Health Care

System

600 South 70th Street Lincoln, NE 68510

Grand Island Division - VA Nebraska Western Iowa Health

Care System

2201 N. Broadwell Ave.

Grand Island, NE 68803

Sioux Falls VA Medical Center 2501 W. 22nd Street, PO Box 5046 Sioux Falls, SD 57117

St. Cloud VA Medical Center 4801 Veterans Dr Saint Cloud, MN

56303

VA Black Hills Health Care System – Hot Springs Campus

500 N 5th St Hot Springs, SD

57747

VA Black Hills Health Care System - Fort Meade Campus

113 Comanche Road Fort Meade, SD 57741

VA IT SECURITY

1. GENERAL. This entire section applies to all acquisitions requiring any Information Security and Privacy language. Contractors, contractor personnel, subcontractors and subcontractor personnel will be subject to the same federal laws, regulations, standards, VA directives and handbooks, as VA personnel regarding information and information system security and privacy.

2. VA INFORMATION CUSTODIAL LANGUAGE.

a. The Government shall receive unlimited rights to data/intellectual property first produced and delivered in the performance of this contract or order (hereinafter “contract”) unless expressly stated otherwise in this contract. This includes all rights to source code and all documentation created in support thereof. The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General. The primary clause used to define computer software license (not data/intellectual property first produced under this contractor or order) is FAR 52.227-19, Commercial Computer Software License.

b. Information made available to the contractor by VA for the performance or administration of this contract will be used only for the purposes specified in the service agreement, SOW, PWS, PD, and/or contract. The contractor shall not use VA information in any other manner without prior written approval from a VA Contracting Officer (CO). The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General.

c. VA information will not be co-mingled with any other data on the contractor’s information systems or media storage systems. The contractor shall ensure compliance with Federal and VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization.

d. VA reserves the right to conduct scheduled or unscheduled audits, assessments, or investigations of contractor Information Technology (IT) resources to ensure information security is compliant with Federal and VA requirements. The contractor shall provide all necessary access to records (including electronic and documentary materials related to the contracts and subcontracts) and support (including access to contractor and subcontractor staff associated with the contract) to VA, VA's Office Inspector General (OIG), and/or Government Accountability Office (GAO) staff during periodic control assessments, audits, or investigations.

e. The contractor may only use VA information within the terms of the contract and applicable Federal law, regulations, and VA policies. If new Federal information security laws, regulations or VA policies become applicable after execution of the contract, the parties agree to negotiate contract modification and adjustment necessary to implement the new laws, regulations, and/or policies.

f. The contractor shall not make copies of VA information except as specifically authorized and necessary to perform the terms of the contract. If copies are made for restoration purposes, after the restoration is complete, the copies shall be destroyed in accordance with VA Directive 6500, VA Cybersecurity Program and VA Information Security Knowledge Service.

g. If a Veterans Health Administration (VHA) contract is terminated for default or cause with a business associate, the related local Business Associate Agreement (BAA) shall also be terminated and actions taken in accordance with VHA Directive 1605.05, Business Associate Agreements. If there is an executed national BAA associated with the contract, VA will determine what actions are appropriate and notify the contactor.

h. The contractor shall store and transmit VA sensitive information in an encrypted form, using VA-approved encryption tools which are, at a minimum, Federal Information Processing Standards (FIPS) 140-2, Security Requirements for Cryptographic Modules (or its successor) validated and in conformance with VA Information Security Knowledge Service requirements.

The contractor shall transmit VA sensitive information using VA approved Transport Layer Security (TLS) configured with FIPS based cipher suites in conformance with National Institute of Standards and Technology (NIST) 800-52, Guidelines for the Selection, Configuration and Use of Transport Layer Security (TLS) Implementations.

i. The contractor’s firewall and web services security controls, as applicable, shall meet or exceed VA’s minimum requirements.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor may use and disclose VA information only in two situations: (i) in response to a qualifying order of a court of competent jurisdiction after notification to VA CO (ii) with written approval from the VA CO. The contractor shall refer all requests for, demands for production of or inquiries about, VA information and information systems to the VA CO for response.

k. Notwithstanding the provision above, the contractor 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 medical records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse or infection with Human Immunodeficiency Virus (HIV). If the contractor is in receipt of a court order or other requests for the above-mentioned information, the contractor shall immediately refer such court order or other requests to the VA CO for response.

l. Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract will be protected and secured in accordance with VA Directive 6500 and Identity and Access Management (IAM) Security processes specified in the VA Information Security Knowledge Service.

m. Any data destruction done on behalf of VA by a contractor shall be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management, VA Handbook 6300.1, Records Management Procedures, and applicable VA Records Control Schedules.

n. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Directive 6500 and NIST 800-88, Guidelines for Media Sanitization prior to termination or completion of this contract. If directed by the COR/CO, the contractor shall return all Federal Records to VA for disposition.

o. Any media, such as paper, magnetic tape, magnetic disks, solid state devices or optical discs that is used to store, process, or access VA information that cannot be destroyed shall be returned to VA.The contractor shall hold the appropriate material until otherwise directed by the Contracting Officer’s Representative (COR) or CO. Items shall be returned securely via VA-approved methods. VA sensitive information must be transmitted utilizing VA-approved encryption tools which are validated under FIPS 140-2 (or its successor) and NIST 800-52. If mailed, the contractor shall send via a trackable method (USPS, UPS, FedEx, etc.) and immediately provide the COR/CO with the tracking information. Self-certification by the contractor that the data destruction requirements above have been met shall be sent to the COR/CO within 30 business days of termination of the contract.

p. All electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.) used to store, process or access VA information will not be returned to the contractor at the end of lease, loan, or trade-in. Exceptions to this paragraph will only be granted with the written approval of the VA CO.

3. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS. Not Required

4. TRAINING. Not Required

5. SECURITY INCIDENT INVESTIGATION.

a. The contractor, subcontractor, their employees, or business associates shall immediately (within one hour) report suspected security / privacy incidents to the VA OIT’s Enterprise Service Desk (ESD) by calling (855) 673-4357 (TTY: 711). The ESD is OIT’s 24/7/365 single point of contact for IT-related issues. After reporting to the ESD, the contractor, subcontractor, their employees, or business associates shall, within one hour, provide the COR/CO the incident number received from the ESD.

b.To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved and the circumstances surrounding the incident, including the following:

(1) The date and time (or approximation of) the Security Incident occurred.

(2) The names of individuals involved (when applicable).

(3) The physical and logical (if applicable) location of the incident.

(4) Why the Security Incident took place (i.e., catalyst for the failure).

(5) The amount of data belonging to VA believed to have been compromised.

(6) The remediation measures the contractor is taking to ensure no future incidents of a similar nature.

c. After the contractor has provided the initial detailed incident summary to VA, they will continue to provide written updates on any new and relevant circumstances or facts they discover. The contractor, subcontractor, and their employes shall fully cooperate with VA or third-party entity performing an independent risk analysis on behalf of VA. Failure to cooperate may be deemed a material breach and grounds for contract termination.

d. VA IT contractors shall follow VA Handbook 6500, Risk Management Framework for VA Information Systems VA Information Security Program, and VA Information Security Knowledge Service guidance for implementing an Incident Response Plan or integrating with an existing VA implementation.

e. 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 the VA Office of 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. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

f. The contractor shall comply with VA Handbook 6500.2, Management of Breaches Involving Sensitive Personal Information, which establishes the breach management policies and assigns responsibilities for the oversight, management and reporting procedures associated with managing of breaches.

g. With respect to unsecured Protected Health Information (PHI), the contractor is deemed to have discovered a data breach when the contractor knew or should have known of breach of such information. When a business associate is part of VHA contract, notification to the covered entity (VHA) shall be made in accordance with the executed BAA.

h. If the contractor or any of its agents fails to protect VA sensitive personal information or otherwise engages in conduct which results in a data breach involving any VA sensitive personal information the contractor/subcontractor processes or maintains under the contract;

the contractor shall pay liquidated damages to the VA as set forth in clause 852.211-76, Liquidated Damages—Reimbursement for Data Breach Costs.

6. INFORMATION SYSTEM DESIGN AND DEVELOPMENT.

a. Information systems designed or developed on behalf of VA at non-VA facilities shall comply with all applicable Federal law, regulations, and VA policies. This includes standards for the protection of electronic Protected Health Information (PHI), outlined in 45 C.F.R. Part 164, Subpart C and information and system security categorization level designations in accordance with FIPS 199, Standards for Security Categorization of Federal Information and Information Systems and FIPS 200, Minimum Security Requirements for Federal Information Systems.

Baseline security controls shall be implemented commensurate with the FIPS 199 system security categorization (reference VA Handbook 6500 and VA Trusted Internet Connections (TIC) Architecture).

b. Contracted new developments require creation, testing, evaluation, and authorization in compliance with VA Assessment and Authorization (A&A) processes in VA Handbook 6500 and VA Information Security Knowledge Service to obtain an Authority to Operate (ATO). VA Directive 6517, Risk Management Framework for Cloud Computing Services, provides the security and privacy requirements for cloud environments.

c.VA IT contractors, subcontractors and third-party service providers shall address and/or integrate applicable VA Handbook 6500, VA Handbook 6517, Risk Management Framework for Cloud Computing Services and Information Security Knowledge Service specifications in delivered IT systems/solutions, products and/or services. If systems/solutions, products and/or services do not directly match VA security requirements, the contractor shall work though the COR/CO to identify the VA organization responsible for governance or resolution. Contractors shall comply with FAR 39.1, specifically the prohibitions referenced.

d. The contractor (including producers and resellers) shall comply with Office of Management and Budget (OMB) M-22-18 and M-23-16 when using third-party software on VA information systems or otherwise affecting the VA information. This includes new software purchases and software renewals for software developed or modified by major version change after the issuance date of M-22-18 (September 14, 2022). The term “software” includes firmware, operating systems, applications and application services (e.g., cloud-based software), as well as products containing software. The contractor shall provide a self-attestation that secure software development practices are utilized as outlined by Executive Order (EO)14028 and NIST Guidance. A third-party assessment provided by either a certified Federal Risk and

Authorization Management Program (FedRAMP) Third Party Assessor Organization (3PAO) or one approved by the agency will be acceptable in lieu of a software producer's self-attestation.

e. The contractor shall ensure all delivered applications, systems and information systems are compliant with Homeland Security Presidential Directive (HSPD) 12 and VA Identity and Access management (IAM) enterprise identity management requirements as set forth in OMB M-19-17, M-05-24, FIPS 201-3, Personal Identity Verification (PIV) of Federal Employees and Contractors (or its successor), M-21-31 and supporting NIST guidance. This applies to Commercial Off-The- Shelf (COTS) product(s) that the contractor did not develop, all software configurations and all customizations.

f. The contractor shall ensure all contractor delivered applications and systems provide user authentication services compliant with VA Handbook 6500, VA Information Security Knowledge Service, IAM enterprise requirements and NIST 800-63, Digital Identity Guidelines, for direct, assertion-based authentication and/or trust-based authentication, as determined by the design and integration patterns. Direct authentication at a minimum must include Public Key Infrastructure (PKI) based authentication supportive of PIV and/or Common Access Card (CAC), as determined by the business need and compliance with VA Information Security Knowledge Service specifications.

g. The contractor shall use VA authorized technical security baseline configurations and certify to the COR that applications are fully functional and operate correctly as intended on systems in compliance with VA baselines prior to acceptance or connection into an authorized VA computing environment. If the Defense Information Systems Agency (DISA) has created a Security Technical Implementation Guide (STIG) for the technology, the contractor may configure to comply with that STIG. If VA determines a new or updated VA configuration baseline needs to be created, the contractor shall provide required technical support to develop the configuration settings. FAR 39.1 requires the population of operating systems and applications includes all listed on the NIST National Checklist Program Checklist Repository.

h. The standard installation, operation, maintenance, updating and patching of software shall not alter the configuration settings from VA approved baseline configuration. Software developed for VA must be compatible with VA enterprise installer services and install to the default “program files” directory with silently install and uninstall. The contractor shall perform testing of all updates and patching prior to implementation on VA systems.

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

j.The contractor-delivered solutions shall reside on VA approved operating systems. Exceptions to this will only be granted with the written approval of the COR/CO.

k. The contractor shall design, develop, and implement security and privacy controls in accordance with the provisions of VA security system development life cycle outlined in NIST 800-37, Risk Management Framework for Information Systems and Organizations: A System Life Cycle Approach for Security and Privacy, VA Directive and Handbook 6500, and VA Handbook 6517.

l. The Contractor shall comply with the Privacy Act of1974 (the Act), FAR 52.224-2 Privacy Act, and VA rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish a VA function.

m. The contractor shall ensure the security of all procured or developed information systems, systems, major applications, minor applications, enclaves and platform information technologies, including their subcomponents (hereinafter referred to as “Information Systems”) throughout the life of this contract and any extension, warranty, or maintenance periods. This includes security configurations, workarounds, patches, hotfixes, upgrades, replacements and any physical components which may be necessary to remediate all security vulnerabilities published or known to the contractor anywhere in the information systems (including systems, operating systems, products, hardware, software, applications and firmware). The contractor shall ensure security fixes do not negatively impact the Information Systems.

n. When the contractor is responsible for operations or maintenance of the systems, the contractor shall apply the security fixes within the timeframe specified by the associated controls on the VA Information Security Knowledge Service. When security fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the contractor shall provide written notice to the VA COR/CO that the patch has been validated as to not affecting the Systems within 10 business days.

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

a. The contractor shall comply with all Federal laws, regulations, and VA policies for Information systems (cloud and non-cloud) that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities. Security controls for collecting, processing, transmitting, and storing of VA sensitive information, must be in place. The controls will be tested by VA or a VA sanctioned 3PAO and approved by VA prior to hosting, operation, maintenance or use of the information system or systems by or on behalf of VA. This includes conducting compliance risk assessments, security architecture analysis, routine vulnerability scanning, system patching, change management procedures and the completion of an acceptable contingency plan for each system. The contractor’s security control procedures shall be the same as procedures used to secure VA-operated information systems.

b. Outsourcing (contractor facility, equipment, or staff) of systems or network operations, telecommunications services or other managed services require Assessment and Authorization (A&A) of the contractor’s systems in accordance with VA Handbook 6500 as specified in VA Information Security Knowledge Service. Major changes to the A&A package may require reviewing and updating all the documentation associated with the change. The contractor’s cloud computing systems shall comply with FedRAMP and VA Directive 6517 requirements.

c. The contractor shall return all electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.) on non-VA leased or non-VA owned IT equipment used to store, process or access VA information to VA in accordance with A&A package requirements. This applies when the contract is terminated or completed and prior to disposal of media. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Information Security Knowledge Service requirements and NIST 800-88. The contractor shall send a self-certification that the data destruction requirements above have been met to the COR/CO within 30 business days of termination of the contract.

d. All external internet connections to VA network involving VA information must be in accordance with VA Trusted Internet Connection (TIC) Reference Architecture and VA Directive and Handbook 6513, Secure External Connections and reviewed and approved by VA prior to implementation. Government-owned contractor-operated systems, third party or business partner networks require a Memorandum of Understanding (MOU) and Interconnection Security Agreements (ISA).

e. Contractor procedures shall be subject to periodic, announced, or unannounced assessments by VA officials, the OIG or a 3PAO. The physical security aspects associated with contractor activities are also subject to such assessments. The contractor shall report, in writing, any deficiencies noted during the above assessment to the VA COR/CO. The contractor shall use VA’s defined processes to document planned remedial actions that address identified deficiencies in information security policies, procedures, and practices. The contractor shall correct security deficiencies within the timeframes specified in the VA Information Security Knowledge Service.

f. All major information system changes which occur in the production environment shall be reviewed by the VA to determine the impact on privacy and security of the system. Based on the review results, updates to the Authority to Operate (ATO) documentation and parameters may be required to remain in compliance with VA Handbook 6500 and VA Information Security Knowledge Service requirements.

g. The contractor shall conduct an annual privacy and security self-assessment on all information systems and outsourced services as required. Copies of the assessment shall be provided to the COR/CO. The VA/Government reserves the right to conduct assessment using government personnel or a third-party if deemed necessary. The contractor shall correct or mitigate any weaknesses discovered during the assessment.

h. VA prohibits the installation and use of personally owned or contractor-owned equipment or software on VA information systems. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW, PWS, PD or contract. All security controls required for government furnished equipment must be utilized in VA approved Other Equipment (OE). Configuration changes to the contractor OE, must be funded by the owner of the equipment. All remote systems must use a VA-approved antivirus software and a personal (host-based or enclave based) firewall with a VA-approved configuration. The contractor shall ensure software on OE is kept current with all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-virus software and the firewall on the non-VA owned OE. Approved contractor OE will be subject to technical inspection at any time.

i. The contractor shall notify the COR/CO within one hour of disclosure or successful exploits of any vulnerability which can compromise the confidentiality, integrity, or availability of the information systems. The system or effected component(s) need(s) to be isolated from the network. A forensic analysis needs to be conducted jointly with VA. Such issues will be remediated as quickly as practicable, but in no event longer than the timeframe specified by VA Information Security Knowledge Service. If sensitive personal information is compromised reference VA Handbook 6500.2 and Section 5, Security Incident Investigation.

j. For cases wherein the contractor discovers material defects or vulnerabilities impacting products and services they provide to VA, the contractor shall develop and implement policies and procedures for disclosure to VA, as well as remediation. The contractor shall, within 30 business days of discovery, document a summary of these vulnerabilities or defects. The documentation will include a description of the potential impact of each vulnerability and material defect, compensating security controls, mitigations, recommended corrective actions, root cause analysis and/or workarounds (i.e., monitoring). Should there exist any backdoors in the products or services they provide to VA (referring to methods for bypassing computer authentication), the contractor shall provide the VA CO/CO written assurance they have permanently remediated these backdoors.

k. All other vulnerabilities, including those discovered through routine scans or other assessments, will be remediated based on risk, in accordance with the remediation timelines specified by the VA Information Security Knowledge Service and/or the applicable timeframe mandated by Cybersecurity & Infrastructure Security Agency (CISA) Binding Operational Directive (BOD) 22-01 and BOD 19-02 for Internet-accessible systems. Exceptions to this paragraph will only be granted with the approval of the COR/CO.

8. SECURITY AND PRIVACY CONTROLS COMPLIANCE TESTING, ASSESSMENT AND

AUDITING.

a. Should VA request it, the contractor shall provide a copy of their (corporation’s, sole proprietorship’s, partnership’s, limited liability company (LLC), or other business structure entity’s) policies, procedures, evidence and independent report summaries related to specified cybersecurity frameworks (International Organization for Standardization (ISO), NIST Cybersecurity Framework (CSF), etc.). VA or its third-party/partner designee (if applicable) are further entitled to perform their own audits and security/penetration tests of the contractor’s IT or systems and controls, to ascertain whether the contractor is complying with the information security, network or system requirements mandated in the agreement between VA and the contractor.

b. Any audits or tests of the contractor or third-party designees/partner VA elects to carry out will commence within 30 business days of VA notification. Such audits, tests and assessments may include the following: (a): security/penetration tests which both sides agree will not unduly impact contractor operations; (b): interviews with pertinent stakeholders and practitioners; (c):

document review; and (d): technical inspections of networks and systems the contractor uses to destroy, maintain, receive, retain, or use VA information.

c. As part of these audits, tests and assessments, the contractor shall provide all information requested by VA. This information includes, but is not limited to, the following: equipment lists, network or infrastructure diagrams, relevant policy documents, system logs or details on information systems accessing, transporting, or processing VA data.

d. The contractor and at its own expense, shall comply with any recommendations resulting from VA audits, inspections and tests. VA further retains the right to view any related security reports the contractor has generated as part of its own security assessment. The contractor shall also notify VA of the existence of any such security reports or other related assessments, upon completion and validation.

e. VA appointed auditors or other government agency partners may be granted access to such documentation on a need-to-know basis and coordinated through the COR/CO. The contractor shall comply with recommendations which result from these regulatory assessments on the part of VA regulators and associated government agency partners.

9. PRODUCT INTEGRITY, AUTHENTICITY, PROVENANCE, ANTI-COUNTERFEIT AND

ANTI-TAMPERING.

a. The contractor shall comply with Code of Federal Regulations (CFR) Title 15 Part 7, “Securing the Information and Communications Technology and Services (ICTS) Supply Chain”, which prohibits ICTS Transactions from foreign adversaries. ICTS Transactions are defined as any acquisition, importation, transfer, installation, dealing in or use of any information and communications technology or service, including ongoing activities, such as managed services, data transmission, software updates, repairs or the platforming or data hosting of applications for consumer download.

b. When contracting terms require the contractor to procure equipment, the contractor shall purchase or acquire the equipment from an Original Equipment Manufacturer (OEM) or an authorized reseller of the OEM. The contractor shall attest that equipment procured from an OEM or authorized reseller or distributor are authentic. If procurement is unavailable from an OEM or authorized reseller, the contractor shall submit in writing, details of the circumstances prohibiting this from happening and procure a product waiver from the VA COR/CO.

c. All contractors shall establish, implement, and provide documentation for risk management practices for supply chain delivery of hardware, software (to include patches) and firmware provided under this agreement. Documentation will include chain of custody practices, inventory management program, information protection practices, integrity management program for sub-supplier provided components, and replacement parts requests. The contractor shall make spare parts available. All contractor(s) shall specify how digital delivery for procured products, including patches, will be validated and monitored to ensure consistent delivery. The contractor shall apply encryption technology to protect procured products throughout the delivery process.

d. If a contractor provides software or patches to VA, the contractor shall publish or provide a hash conforming to the FIPS Security Requirements for Cryptographic Modules (FIPS 140-2 or successor).

e. The contractor shall provide a software bill of materials (SBOM) for procured (to include licensed products) and consist of a list of components and associated metadata which make up the product. SBOMs must be generated in one of the data formats defined in the National Telecommunications and Information Administration (NTIA) report “The Minimum Elements for a Software Bill of Materials (SBOM).”

f. Contractors shall use or arrange for the use of trusted channels to ship procured products, such as U.S. registered mail and/or tamper-evident packaging for physical deliveries.

g. Throughout the delivery process, the contractor shall demonstrate a capability for detecting unauthorized access (tampering).

h. The contractor shall demonstrate chain-of-custody documentation for procured products and require tamper-evident packaging for the delivery of this hardware.

10. VIRUSES, FIRMWARE AND MALWARE.

a. The contractor shall execute due diligence to ensure all provided software and patches, including third-party patches, are free of viruses and/or malware before releasing them to or installing them on VA information systems.

b. The contractor warrants it has no knowledge of and did not insert, any malicious virus and/or malware code into any software or patches provided to VA which could potentially harm or disrupt VA information systems. The contractor shall use due diligence, if supplying third-party software or patches, to ensure the third-party has not inserted any malicious code and/or virus which could damage or disrupt VA information systems.

c. The contractor shall provide or arrange for the provision of technical justification as to why any “false positive” hit has taken place to ensure their code’s supply chain has not been compromised. Justification may be required, but is not limited to, when install files, scripts, firmware, or other contractor-delivered software solutions (including third-party install files, scripts, firmware, or other software) are flagged as malicious, infected, or suspicious by an anti-virus vendor.

d. The contractor shall not upload (intentionally or negligently) any virus, worm, malware or any harmful or malicious content, component and/or corrupted data/source code (hereinafter “virus or other malware”) onto VA computer and information systems and/or networks. If introduced (and this clause is violated), upon written request from the VA CO, the contractor shall:

(1) Take all necessary action to correct the incident, to include any and all assistance to VA to eliminate the virus or other malware throughout VA’s information networks, computer systems and information systems; and

(2) Use commercially reasonable efforts to restore operational efficiency and remediate damages due to data loss or data integrity damage, if the virus or other malware causes a loss of operational efficiency, data loss, or damage to data integrity.

11. CRYPTOGRAPHIC REQUIREMENT.

b. The contractor shall use only approved cryptographic methods as defined in FIPS 140-2 (or its successor) and NIST 800-52 standards when enabling encryption on its products.

c. The contractor shall provide or arrange for the provision of an automated remote key-establishment method which protects the confidentiality and integrity of the cryptographic keys.

d. The contractor shall ensure emergency re-keying of all devices can be remotely performed within 30 business days.

e. The contractor shall provide or arrange for the provision of a method for updating cryptographic primitives or algorithms.

12. PATCHING GOVERNANCE

a. The contractor shall provide documentation detailing the patch management, vulnerability management, mitigation and update processes…

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