36C25526Q0306_1.docx

36C25526Q0306

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1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

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

36C25526Q0306 -2026 Kobulnicky, Erika/Erika.Kobulnicky@va.gov 913-946-1991 -2026

7:00 AM

CDT

36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048 X 325412 1300 Employees N/A X Department of Veterans Affairs Robert J. Dole VA Medical Center Nuclear Medicine Department 5500 E. Kellogg Avenue Wichita KS 67218-1607 36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048

36C255 Department of Veterans Affairs Financial Services Center http://www.fsc.va.gov/einvoice.asp Austin TX 877-353-9791 512-460-5429 See CONTINUATION Page Radiopharmaceuticals in support of Nuclear Medicine at the Robert J. Dole Medical Center in Wichita, KS,

1. This solicitation is a request for quotes for Radio-pharmaceutical requirements in accordance with the Statement of Work (SOW).

2. This solicitation is for a five (5) Year IDIQ with five twelve-month Ordering Periods:

08/ /2026 -

/3 /2031.Individual task orders will be issued by the NCO 15 contracting officer (CO).

3. This procurement is being competed in accordance with FAR part 12 Simplified Acquisition Procedures.

4. Evaluation Criteria: Price, Technical Capability and Past Performance.

5. Questions are due no later than T hurs day

/2026, 10AM

6. IMPORTANT: For additional details see B.2 SOW, B.3 Price Schedule, and Addendum to FAR 52.212-1 Instructions to Offerors See CONTINUATION Page X X X one(1) Buchanan, Lisa A.

Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT:

Contracting Officer 36C255 Lisa Buchanan/ Lisa.Buchanan@va.gov Contract Specialist 36C255 Erika Kobulnicky/ Erika.Kobulnicky@va.gov Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048

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:

Financial Services Center http://www.fsc.va.gov/einvoice.asp ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

36C25526Q0306

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B.2 STATEMENT OF WORK

Radiopharmaceuticals - Robert J. Dole VA Medical Center

1. Scope and General Description:

Radiopharmaceutical preparation of doses, tagging of blood, and testing shall be performed at the contractor’s facility provided by a board-certified radiopharmacist and delivered to the Robert J. Dole VA Medical Center (VAMC), Nuclear Medicine Department, at 5500 E. Kellogg Wichita, KS. The Government anticipates awarding an IDIQ contract with five (5) twelve-month ordering periods: 08/01/2026 – 07/31/2031.

The contractor shall furnish all labor, supervision, equipment, materials, licenses, permits, transportation, and incidentals necessary to provide the radiopharmaceutical products and services described in this Statement of Work (SOW).

The Contractor shall provide services and support at the locations identified in this Statement of Work. The Government reserves the right to add, remove, or modify locations and facilities as mission requirements evolve across the current and future operational footprint. The Contractor shall accommodate these changes within the scope of the contract without disruption to services. Any adjustments to pricing, schedule, or resources resulting from such changes shall be addressed through the appropriate contractual modification process in accordance with the applicable Changes clause.

2. Requirements:

The contractor shall supply, at a minimum, the radiopharmaceuticals and related products listed below. All radiopharmaceuticals shall be calibrated for 0600 Central Time, shall meet required radionuclidic and radiochemical purity standards in accordance with USP and FDA requirements, and shall have adequate remaining expiration at the time of delivery to support clinical use.

Tc99m non-HEU Thallium-201

Estimated quantities are provided for planning purposes only and do not obligate the Government to order these exact amounts.

3. Duties:

a. The contractor’s dispensing facility must either: (1) be located within a fifty (50)‑mile driving radius of the Robert J. Dole VAMC, or (2) demonstrate the ability to deliver ordered radiopharmaceuticals to the VAMC within one (1) hour of required delivery time for emergent orders.

Contractor shall deliver emergent orders within one (1) hour of telephonic or electronic order confirmation, 24 hours per day, 7 days per week, including Federal holidays.

b. The contractor shall hold and maintain, throughout the period of performance, a current, unrevoked U.S. Nuclear Regulatory Commission (NRC) and/or Agreement State license and, as applicable, a U.S. Food and Drug Administration (FDA) registration/license to produce and distribute radiopharmaceuticals for human administration, and a license to receive and dispose of radioactive waste.

c. All personnel assigned by the contractor to perform services under this contract shall be licensed as pharmacists, radiopharmacists, or nuclear medicine technologists, as applicable, under State law.

d. The contractor shall immediately, but in no event later than one (1) business day after notice, notify the Contracting Officer (CO) and Contracting Officer’s Representative (COR) in writing of any actual, proposed, or threatened action by the NRC, an Agreement State, or FDA to suspend, revoke, restrict, or otherwise modify any license, registration, or authorization held by the contractor or any subcontractor that may affect contract performance.

e. The contractor shall be capable of transitioning technetium‑based products from highly enriched uranium (HEU) to low enriched uranium (LEU) sources in accordance with Department of Veterans Affairs policy and applicable law when directed.

4. Work Hours:

Regular work hours for routine, non-emergent deliveries are: Monday through Friday 6:00a.m. to 4:30p.m., excluding Federal holidays and any other day specifically declared by the President of the United States to be a national holiday.

The contractor shall provide on-call/emergency delivery capability 24 hours per day, 7 days per week, including Federal holidays for orders designated as “emergency” by the COR or ordering official.

5. Security Requirements:

a. The contractor shall be responsible for maintaining appropriate information system security controls for any automated data processing (ADP) systems it uses to receive, process, store, or transmit VA information consistent with VA information security and privacy requirements applicable to contractors.

b. The contractor shall safeguard and maintain all patient information in the strictest confidence in accordance with the Privacy Act of 1974, the Health Insurance Portability and Accountability Act (HIPAA) and implement regulations, Va-specific privacy policies, and all other applicable Federal and State laws and regulations. Contractor shall comply with VA Handbook 6500 and all applicable VA information security and privacy requirements as incorporated elsewhere in the contract.

6. Period of Performance It is the Government’s intent to have a base period plus four (4) ordering periods, as follows:

The Government reserves the right to exercise ordering periods in accordance with the terms and conditions of the contract.

7. Delivery:

a. Orders normally will be placed by 3:00 pm. Delivery shall be required by 6:00 am the following workday. Subject to the contact maximum quantities and funding limitations, there shall be no restriction on the number of orders and delivered placed by the Robert J. Dole VAMC Nuclear Medicine Technician’s per day.

b. Each delivery order must include, at a minimum:

· Patient identifier (per VA privacy policies)

· Patients’ name

· Contract line-item number(s) (CLIN) and quantity

· Required activity and calibration time

· Delivery date and time

· Applicable VA purchase order number.

· Scheduled delivery time(s)

c. Deliveries will incorporate sufficient lead or other high-density metal shielding to comply with all applicable federal and/or state standards relating to shipment of radioactive material including NRC and U.S. Department of Transportation (DOT) requirements.

d. Deliveries shall be accepted at the Robert J. Dole VAMC Nuclear Medicine Department or other designated location. The contractor shall contact the COR or designee prior to delivery to coordinate delivery and acceptance.

Deliveries will be received and inspected by the COR or designated Government representative at time of delivery, in accordance with the Inspection and Acceptance provisions of the contract.

e. Unused radiopharmaceuticals, including bulk doses, that are not administered and are returnable under applicable NRC/DOT safety and regulatory requirements, shall be returned for credit on the next business day, or disposed of by the contractor as radioactive waste if agreed in writing, in accordance with contractor’s license and applicable regulations.

Credit will be issued at 10% of the unit price for returns made within hours of scheduled delivery and before expiration, unless otherwise negotiated.

f. Orders designated “when needed” may be requested during regular work hours, after hours, on weekends, and on Federal holidays, and may be designated “emergency” by the ordering official. The contractor shall provide a 24/7 point of contact (telephone number) for emergency orders. Access to this location during non-work hours shall be obtained by contacting a Nuclear Medicine Technician at 316-685-2221 EXT: 53653.

g. If shipments are scheduled to be delivered specifically on Mondays and Monday is a Federal holiday; delivery shall occur on the next regular workday unless otherwise requested by the ordering official.

h. Orders can be placed by telephone, secure fax, or secure electronic transmission (e.g. web-based ordering system (as authorized by the CO).

i. The agreed time of delivery, as specified or mutually agreed upon at the time of receipt of a telephone or electronic order, is mandatory. Failure to deliver by the agreed time may constitute a performance deficiency and may be grounds for remedies up and including termination for cause, in accordance with the contract and applicable FAR/VAAR clauses.

8. Person Authorized to Place Orders:

In addition to the Contracting Officer, the COR is authorized to place orders under this contract, as are certified Nuclear Medicine Technologists employed by the Robert J. Dole VAMC who are identified in writing by the COR and approved by the CO. The CO will maintain a current list of individuals authorized to place orders under this contract. The list will include names, titles, and specimen signatures, and may be updated by written notice from the CO without a formal contract modification.

9. Inspection and Acceptance

a. The Government will inspect all radiopharmaceuticals and related services at the point of delivery for compliance with order requirements (product, activity, calibration time, labeling, shielding, and documentation).

b. Performance standards:

· Accuracy of product and activity: 99% of doses delivered per month shall match the ordered radiopharmaceutical and activity within ±10% of prescribed activity at the stated calibration time, consistent with applicable standards.

· On‑time delivery: 98% of routine orders per month shall be delivered by the required delivery time; 95% of emergent orders shall be delivered within one (1) hour of order confirmation.

· Documentation: 100% of deliveries shall include documentation of patient identifier (as authorized), product, lot number, activity, calibration time, expiration time, and order number.

c. Nonconforming products (incorrect product, out‑of‑tolerance activity, incorrect labeling, or late delivery) may be rejected at no cost to the Government and shall be replaced as soon as practicable, but no later than two (2) hours after notification, unless otherwise agreed by the COR.

d. Inspection and acceptance are subject to the Inspection of Supplies or Inspection of Services clause incorporated in Section E of the contract.

10. Contractor Personnel Requirements

a. The contractor shall ensure all personnel who deliver radiopharmaceuticals to VA facilities:

· Carry valid government‑issued photo identification and contractor identification as required by VA security policies.

· Comply with VA access control, escort, and safety rules while on VAMC premises.

b. Contractor personnel shall receive initial and annual training, as applicable, on the following topics:

· Safe handling, transport, and delivery of radioactive materials.

· VA privacy and security requirements for handling patient information.

· Facility‑specific safety and emergency procedures, if required by the VAMC.

c. The contractor shall immediately remove from performance under this contract any employee who is determined by the CO to be unfit for duty or who fails to comply with VA policies and shall provide a qualified replacement within one (1) business day for routine work, or sooner if required for emergent deliveries.

11. Applicable Laws, Regulations, and Standards The contractor shall comply with all applicable Federal, State, and local laws, regulations, and standards governing the manufacture, compounding, labeling, handling, transport, and disposal of radiopharmaceuticals, including but not limited to:

· U.S. Nuclear Regulatory Commission (NRC) regulations and applicable Agreement State regulations.

· U.S. Food and Drug Administration (FDA) regulations applicable to radiopharmaceuticals.

· U.S. Department of Transportation (DOT) regulations for hazardous and radioactive materials transport.

· Privacy Act of 1974 and HIPAA, as implemented in VA regulations and policy.

· Applicable State pharmacy practice and nuclear pharmacy regulations.

Nothing in this SOW supersedes or alters the terms and conditions of the contract clauses incorporated in the contract.

12. Contract Administration Data All contract administration functions will be retained by the Department of Veterans Affairs.

The Contracting Officer will be the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer will be authorized to make commitments or issue changes that affect price, quantity, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

13. Contracting Officer’s Representative Pursuant to VAAR Provision 852.270-1, Representatives of Contracting Officer, the designated representative for this contract will be determined at award.

14. Acronyms and Definitions CDR: Contract Discrepancy Report. Report issued by the Government to the contractor to document a supply or service found to be unacceptable during contract performance.

CLIN: Contract Line-Item Number. Unit of work (or service) to be performed (or delivered) by the contractor as a pay item.

CO: Contracting Officer. A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

COR: Contracting Officer’s Representative. An individual, including a Contracting Officer’s Representative (COR), designated and authorized in writing by the contracting officer to perform specific technical or administrative functions.

QA: Quality Assurance. Actions taken by the government to assure contracted services meet SOW requirements.

15. Personnel Non-Personal Services This is a non-personal services contract. Personnel rendering services under this contract are not subject either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the government and its employees. The Government shall not exercise any supervision or control over the contract service performing services herein. Such contract service s shall be accountable solely to the Contractor who, in turn, is responsible to the Government. Contractor Compliance with the Immigration and Nationality Act of 1952 The Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to Department of Veterans Affairs patient referrals.

16. Hours of Operations Business hours for the VAMC follow:

a. Administrative hours: Monday through Friday, 8:00 a.m. - 4:30 p.m.

b. National Holidays: The 11 holidays observed by the Federal Government are:

New Year’s Day;

Martin Luther King’s Birthday;

Presidents Day;

Memorial Day;

Juneteenth Independence Day Independence Day;

Labor Day;

Columbus Day;

Veterans Day;

Thanksgiving;

Christmas; and any other day specifically declared by the President of the United States to be a national holiday.

c. Off-Duty hours: Friday through Monday, 4:30 p.m. - 8:00 a.m.; Monday through Thursday, 4:30 pm – 8:00 am.

17. Quality Control CONTRACT PERFORMANCE MONITORING. The COR may perform surveillance of services by any of the methods listed below:

a. Observing actual performance;

b. Inspecting the services to determine whether or not the performance meets the performance standards; and

c. Review of any other appropriate records.

1. When unacceptable performance occurs, the COR shall inform the Contractor and the Contracting Officer. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file.

When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR) and present it to the contractor program manager. The Contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the Contractor is required to prepare a corrective action plan to document how the Contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the Contractor has to present this corrective action plan to the COR. The Government shall review the Contractor corrective action plan to determine acceptability. Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the Contracting Officer.

2. Pursuant to VAAR Provision 852.270-1, Representatives of Contracting Officer representative(s); The Government shall periodically evaluate the Contractor performance by appointing a Contracting Officers Representative (COR) to monitor performance to ensure services are received. The Government representative(s) shall evaluate the Contractor performance through inspections of observations, inspection of services or any other form of documentation and all complaints from VA personnel. The Government may inspect as each task is completed or increase the number of quality assurance inspections if deemed appropriate because of repeated failures or because of repeated customer complaints. Likewise, the Government may decrease the number of quality assurance inspections if performance dictates. The Government Contracting Officer shall make final determination of the validity of customer complaint(s).

3. If any of the services do not conform to contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by re-performance, the Government may require the Contractor to take necessary action to ensure that future performance conforms to contract requirements at no additional cost to the Government.

18. Contract Security

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 certainmedical 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 VA CO.

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 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.

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.

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).

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.

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.

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

3. Contractors believe 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.

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.

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.

TRAINING

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. 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

3. 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].

4. 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.

5. 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.

SECURITY INCIDENT INVESTIGATION

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.

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:

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

· The names of individuals involved (when applicable).

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

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

· The amount of data belonging to VA believed to have been compromised.

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

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.

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.

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.

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.

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.

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.

INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE OR USE.

This entire section applies to information systems, systems, major applications, minor applications, enclaves, and platform information technologies (cloud and non- cloud) hosted, operated, maintained, or used on behalf of VA at non-VA facilities.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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…