36C24625Q0085_1.docx

36C24625Q0085

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

652-25-1-157-0022 36C24625Q0085 01-06-2025 Tiara White 757-251-5761 01-10-2025

12PM

EST

Tiara White Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton

VA

23667 X X 811210 $34 Million Net 30 N/A X Central Virginia VA Health Care System 1201 Broad Rock Blvd.

Richmond

VA

23249 Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton

VA

23667

Department of Veterans Affairs Financial Services Center

PO BOX 149971

Austin

TX

78714-9971 512-460-5049 512-460-5221 x See CONTINUATION Page Sakura Tissue Tek Lab Equipment Service Agreement and Preventive Maintenance at the Central Virginia Health Care System in Richmond, see continuation pages for SOW.

All Offerors shall be registered and current in the System for Award Management (SAM) database at time of offer submission and maintain active registration until contract award, completion of performance, and final payment.

See attached Price/Cost Schedule in Section B.4 for item description and quantity; and complete all requirements as instructed.

See CONTINUATION Page X X X Tiara White Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

No Text

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 36C246 Tiara White Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667

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.

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

B.2 STATEMENT OF WORK

1. Contract Title. Sakura Tissue-Tek Lab Equipment Service Agreement

2. Background.

The Central Virginia VA Health Care System is requesting maintenance and repair service from Sakura for Sakura Brand Tissue-Tek Lab Equipment at the Richmond VA Medical Center from January 10, 2025, through January 09, 2026. Services are to include preventative and corrective maintenance.

3. Scope.

The equipment covered under this service agreement is listed in the table below and is to include any components of the parent systems. The partnership agreement is to provide preventative and corrective maintenance for the Sakura brand Tissue-Tek Lab Equipment at the Hunter Holmes McGuire VAMC. The period January 10, 2025, through January 09, 2026.

4. Specific Tasks.

The Partnership Service Agreement is to include:

· Annual preventative maintenance.

· On-site.

· All travel, labor, and parts included.

· All services to be conducted between 8:30 am and 4:30 pm EST, Monday through Friday, excluding holidays.

· Corrective Maintenance upon demand.

· Telephone support.

· All travel, labor, and parts included if needed.

· Contractor shall respond within one business day either by telephone or an on-site visit.

· All parts, labor, and travel are included.

· All technicians must be OEM factory trained technicians to perform maintenance on the equipment and provide proof of training.

· All parts must be OEM certified.

5. DEFINITIONS/ACRONYMS:

1. RICHMOND VAMC – Hunter Holmes McGuire VA Medical Center, located in Richmond, VA.

J. OEM – Original Equipment Manufacturer.

6. CONFORMANCE STANDARDS:

0. Contract service shall ensure that the equipment functions in conformance with the specifications used when the equipment was procured by the VAMC, and any upgrades/updates, as well as following most current published standards/ specifications/regulations:

Manufacturer’s specifications, Association for the Advancement of Medical Instrumentation (AAMI), Joint Commission for the Accreditation of Healthcare Organizations (JCAHO), National Fire Protection Agency 99 (NFPA 99) and 70 (NFPA 70), Center for Device and Radiological Health (CDRH), Original Equipment Manufacturer (OEM), American Hospital Association (AHA), Institute of Electrical And Electronic Engineers (IEEE), Occupational Safety and Health Administration (OSHA), College of American Pathologists (CAP), Richmond VAMC standard operating procedures, and any other Federal, State, and Local regulations pertaining to the equipment listed for this contract.

7. HOURS OF COVERAGE:

8. SCHEDULED MAINTENANCE

1. RICHMOND VAMC Biomedical Engineering technician(s) shall perform scheduled PM’s. Contractor shall provide to Biomedical Engineering recommended P.M. procedures and checklists with worksheet originals indicating work to be performed and actual values obtained, if applicable. Scheduled maintenance shall include an itemized list of the procedures performed, including electrical safety.

1. Contractor shall perform one (1) Quality Assurance Review, outside of scheduled preventative maintenance visits, per year to ensure that equipment performs in accordance with Equipment Performance Section 2. The reviews shall be performed jointly by contractor and RICHMOND VAMC Biomedical engineering technician(s) during the hours defined in the preventive maintenance schedule.

1. Hardware/firmware/software updates shall be scheduled and performed during normal hours of coverage.

1. Contractor shall provide an outline of the Quality Assurance Review and scheduled maintenance to the COR within 15 days after the contract is awarded. Any changes to the schedule shall be coordinated and approved by the COR.

9. UNSCHEDULED MAINTENANCE (Emergency Repair Service)

1. Contractor and Biomedical Engineering shall maintain the equipment in accordance with Section 2 Equipment Performance. Contractor will provide, in addition to the Quality Assurance Review, unlimited telephone technical support and 100% off parts for service calls. These service calls may be used for any maintenance or repair service as determined by Biomedical Engineering.

1. Response Time: Contractor 's FSE or Technical Support must respond by phone to Biomedical Engineering within one (1) hour after receipt of telephoned notification during normal duty 8:30 am to 4:30 pm Monday through Friday. If the problem cannot be corrected by Biomedical Engineering, the FSE will be on site within twenty-four (24) business hours of notification. Changes to response time must be approved by the CO and COR in advance.

10. PARTS - ITEMS

The contractor shall furnish parts. The contractor shall maintain quantity of parts including unique and/or high mortality replacement parts in such a manner as to be available for shipment within 24 consecutive hours of request. All parts supplied shall be compatible with existing equipment. The contract shall include all parts. Contract parts coverage is to include all system options, third party pass thru devices, such as, compact disk devices, remote workstations, etc. and will include all manufacturer supplied software including that used by third party devices. The contractor shall use OEM new or rebuilt parts. All parts shall perform identically to the original equipment specifications.

11. SERVICE MANUALS/TOOLS/EQUIPMENT

1. The RICHMOND VAMC shall not provide tools, test equipment, service manuals, or service diagnostic software to the contractor. Contractor shall provide all tools, test equipment, service manuals, and/or service diagnostic software. Contractor shall obtain, have on file, and make available to its FSE all operational and technical documentation (such as operational and service manuals, schematics, diagnostic software, and parts lists) which are necessary to meet the performance requirements of this contract. The location and listing of the service manuals, by name and/or the manuals themselves shall be provided to the CO upon request.

1. Contractor shall provide the RICHMOND VAMC Biomedical Engineering copies of all documentation that pertains to any hardware, software, or firmware upgrade or repair. Contractor shall provide to the RICHMOND VAMC Biomedical Engineering copies of the latest version(s) of all technical documentation and licensing agreements, which shall include operational and service manuals, schematics, diagnostic software, and parts lists. RICHMOND VAMC Biomedical Engineering shall have access to the same operation, service, and documentation as the OEM's FSE. Contractor shall provide to the RICHMOND VAMC Biomedical Engineering OEM Service Bulletins for the equipment listed in Part I.

12. DOCUMENTATION/REPORTS:

1. At the completion of each service call (scheduled or unscheduled), Contractor/FSE shall provide a detailed ESR. The ESR shall, at a minimum, document the following information legibly and in complete detail:

1. Name of contractor and contract number.

1. Name of the FSE performing services.

1. Contractor Service ESR number/log number.

1. Date, time (starting and ending), equipment downtime and hours on-site for service call.

1. Identification of equipment to be serviced: I.D. number, Manufacturer's name, device name, model number, serial number, and any other Manufacturer's identification numbers.

1. Description of problem reported by Biomedical Engineering.

1. Any additional charges claimed must be approved by Biomedical Engineering before service has commenced.

13. REPORTING REQUIREMENTS:

Contractor shall be required to report to Biomedical Engineering to check in. This check in is mandatory. The FSE shall check out with Biomedical Engineering and submit the ESR(s) to Biomedical Engineering. All ESR shall be submitted to Biomedical Engineering for an "acceptance signature". If Biomedical Engineering is unavailable, a signed, authorized copy of the ESR will be sent to Biomedical Engineering. VA Biomedical Engineering Contact Person(s): COR or Biomedical Engineering by phone at 804-675-3829 or in Location (Room Number/Building): 2K141-500. The contractor shall provide the COR telephone number(s) to contact the Service Department or FSE.

14. PAYMENTS AND ADDITIONAL CHARGES

1. PAYMENTS: Invoices will be paid IN ARREARS monthly. (If the Contractor prefers quarterly, or semiannually, permission can be granted for other than by a monthly basis by the CO). The Contractor shall mail the invoices to the address provide on the Continuation Sheet of the SF 1449. Invoices, MUST INCLUDE, at a minimum, the following information: Contractor’s name, address, phone number, contract or purchase order number, period of service the billing covers, list of equipment items covered during the stated period of service and invoice amount. Invoice shall be submitted electronically for payment in accordance with VAAR 852.232-72, Electronic Submission of Payment Requests, via VA’s Electronic Invoice Presentment and Payment System (www.fsc.va.gov/einvoice.asp).

1. REPORTING REQUIRED FOR SERVICES BEYOND THE CONTRACT SCOPE: The Contractor shall immediately, but not later than twenty-four (24) hours after discovery, notify the CO and the COR, IN WRITING of the existence or the development of any defects in, or repairs required to the schedule of equipment which the Contractor considers not to be responsible for under the terms of the contract. The Contractor shall furnish the CO and COR with a written estimate of the cost to make necessary repairs.

1. ADDITIONAL CHARGES: There shall be no additional charge for time spent at the site (during, or after the normal hours of coverage) awaiting the arrival of additional FSE and/or delivery of parts.

15. CONDITION OF EQUIPMENT:

Contractor shall accept responsibility for the equipment described in Part I in "as is" condition. Failure to inspect the equipment prior to contract award will not relieve Contractor from performance of the requirements of this contract.

16. COMPETENCY OF PERSONNEL SERVICING EQUIPMENT:

17. TEST EQUIPMENT:

Prior to commencement of work on this contract, Contractor shall provide the RICHMOND VAMC with a copy of the current calibration certification of all test equipment to be used by the Contractor on RICHMOND VAMC equipment. This certification shall also be provided on a periodic basis when requested by the RICHMOND VAMC. Test equipment calibration shall be traceable to a national standard.

18. IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS:

A. Contractor FSE shall always wear visible identification while on the premises of the RICHMOND VAMC. It is the responsibility of Contractor FSE to park in the appropriate designated parking areas. Information on parking is available from the VA Police Service. The RICHMOND VAMC will not invalidate or make reimbursement for parking violations of Contractor’s FSE under any conditions. Smoking is prohibited inside any buildings at the RICHMOND VAMC. Possession of weapons is prohibited.

1. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

19. INSURANCE:

1. Contractors are required to have Property Damage Liability insurance coverage of at least $500,000 unless otherwise approved by the CO and COR.

20. EQUIPMENT MODIFICATIONS/UPDATES:

1. Equipment modifications are divided into two kinds; 1) Normal functional improvements that assure that the equipment is operating at the peak of performance and 2) Enhancing improvements are optional improvements that change the equipment’s original design to allow for supplementary or additional functions.

1. Normal functional improvements shall be provided at no cost to VA within six (6) months after each version is released. Installation shall be done at no additional cost to the government during normal working hours, unless requested by the COR.

1. Enhancing improvements are optional to VA. If the COR has determined that VA requires such enhancing improvements, it shall be considered outside of the scope of this contract and processed as a separate procurement.

1. All modifications, updates, enhancements, etc., must be scheduled in advance with the COR. CO and COR must receive notice at least five (5) full business days in advance before any equipment updates, enhancements, and modifications are begun along with justification (if Vendor-suggested modification), estimated costs (if applicable), probable effect on equipment operation, and needs for new or additional in-service training.

1. Documentation must be provided to Biomedical Engineering when software upgrades/updates are installed. Documentation will include what was installed, how it was installed, and where it was installed on the system. Documentation will include parts list, calibration procedures, and test procedures, if applicable.

21. Performance Monitoring

The vendor will submit service documentation to the COR for proof of work completed. The COR will inspect the work to ensure that the vendor is meeting the standards of the contract.

22. Security Requirements Attached language per requirements on the 6500.6 (VARS) worksheet.

23. Place of Performance.

Central Virginia VA Health Care System 1202 Broad Rock Blvd.

Richmond, VA 23249

24. Period of Performance.

36C24625Q0085 January 10, 2025, through January 09, 2026 Page 1 of Page 1 of B.3 APPENDIX C — VA INFORMATION AND INFORMATION SYSTEM SECURITY AND PRIVACY LANGUAGE FOR INCLUSION IN CONTRACTS, AS APPROPRIATE NOTE: Any sections (1-14) which DO NOT apply should not be included in the Statement of Work (SOW), Performance Work Statement (PWS), Product Description (PD) or contract.

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. This entire section applies to all acquisitions requiring any Information Security and Privacy 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), e.

C-and/or Government Accountability Office (GAO) staff during periodic control assessments, audits, or investigations.

f. 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.

g. 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.

h. 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.

i. 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.

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

k. 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.

l. 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 m.

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.

n. 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.

o. 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.

p. 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.

q. 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.

r. 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.

This section applies when any person requires access to 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.

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees and subcontractors only to the extent necessary to perform the services specified in the solicitation or contract. This includes indirect entities, both affiliate of contractor/subcontractor and agent of contractor/subcontractor.

b. Contractors and subcontractors shall sign the VA Information Security Rule of Behavior (ROB) before access is provided to VA information and information systems (see Section 4, Training, below). The ROB contains the minimum user compliance requirements and does not supersede any policies of VA facilities or other agency components which provide higher levels of protection to VA’s information or information systems. Users who require privileged access shall complete the VA elevated privilege access request processes before privileged access is granted.

c. All contractors and subcontractors working with VA information are subject to the same security investigative and clearance 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 shall be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office of Human Resources and Administration/Operations, Security and Preparedness (HRA/OSP) is responsible for these policies and procedures. Contract personnel who require access to classified information or information systems shall have an appropriate security clearance. Verification of a Security Clearance shall be processed through the Special Security Officer located in HRA/OSP. Contractors shall conform to all requirements stated in the National Industrial Security Program Operating Manual (NISPOM).

d. All contractors and subcontractors shall comply with conditions specified in VAAR 852.204-71(d); Contractor operations required to be in United States. All contractors and subcontractors working with VA information must be permanently located within a jurisdiction subject to the law of the United States or its Territories to the maximum extent feasible. If services are proposed to be performed abroad the contractor must state where all non-U.S. services are provided. The contractor shall deliver to VA a detailed plan specifically addressing communications, personnel control, data protection and potential legal issues. The plan shall be approved by the COR/CO in writing prior to access being granted.

e. The contractor shall notify the COR/CO in writing immediately (no later than 24 hours) after personnel separation or occurrence of other causes. Causes may include the following:

(1) Contractor/subcontractor personnel no longer has a need for access to VA information or VA information systems.

C-4

(2) Contractor/subcontractor personnel are terminated, suspended, or otherwise has their work on a VA project discontinued for any reason.

(3) Contractor believes their own personnel or subcontractor personnel may pose a threat to their company’s working environment or to any company- owned property. This includes contractor-owned assets, buildings, confidential data, customers, employees, networks, systems, trade secrets and/or VA data.

(4) Any previously undisclosed changes to contractor/subcontractor background history are brought to light, including but not limited to changes to background investigation or employee record.

(5) Contractor/subcontractor personnel have their authorization to work in the United States revoked.

(6) Agreement by which contractor provides products and services to VA has either been fulfilled or terminated, such that VA can cut off electronic and/or physical access for contractor personnel.

f. In such cases of contract fulfillment, termination, or other causes; the contractor shall take the necessary measures to immediately revoke access to VA network, property, information, and information systems (logical and physical) by contractor/subcontractor personnel. These measures include (but are not limited to): removing and then securing Personal Identity Verification (PIV) badges and PIV – Interoperable (PIV-I) access badges, VA-issued photo badges, credentials for VA facilities and devices, VA-issued laptops, and authentication tokens. Contractors shall notify the appropriate VA COR/CO immediately to initiate access removal.

g. Contractors/subcontractors who no longer require VA accesses will return VA- issued property to VA. This property includes (but is not limited to): documents, electronic equipment, keys, and parking passes. PIV and PIV-I access badges shall be returned to the nearest VA PIV Badge Issuance Office. Once they have had access to VA information, information systems, networks and VA property in their possessions removed, contractors shall notify the appropriate VA COR/CO.

4. TRAINING. This entire section applies to all acquisitions which include section 3.

a. All contractors and subcontractors requiring access to VA information and VA information systems shall successfully complete the following before being granted access to VA information and its systems:

(1) VA Privacy and Information Security Awareness and Rules of Behavior course (Talent Management System (TMS) #10176) initially and annually thereafter.

(2) C-

(3) Sign and acknowledge (electronically through TMS #10176) understanding of and responsibilities for compliance with the Organizational Rules of Behavior, relating to access to VA information and information systems initially and annually thereafter; and

(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system or information access [to be defined by the VA program official and provided to the VA CO for inclusion in the solicitation document – i.e., any role- based information security training].

b. The contractor shall provide to the COR/CO a copy of the training certificates and certification of signing the Organizational Rules of Behavior for each applicable employee within five days of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the required training is complete.

5. SECURITY INCIDENT INVESTIGATION. This entire section applies to all acquisitions requiring any Information Security and Privacy language.

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.

(7)

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. This entire section applies to information systems, systems, major applications, minor applications, enclaves, and platform information technologies (to include the subcomponents of each) designed or developed for or on behalf of VA by any non-VA entity.

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, f.

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.

g. 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.

h. 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.

i. 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.

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

k. 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.

l. 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.

m.

n. 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.

o. 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.

p. 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.

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