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

36C25026Q0724 07-20-2026

Kellie Konopinski 734-222-4330 08-13-2026

11:00AM EDT

36C250 Department of Veterans Affairs Network Contracting Office 10 Suite 210 3140 Governors Place Blvd Kettering OH 45409-1337

X

325412

1300 Employees

N/A

X

36C506

Department of Veterans Affair See SOW for addresses VA Ann Arbor Healthcare System Toledo VA Clinic

36C250

Department of Veterans Affairs Network Contracting Office 10 Suite 210 3140 Governors Place Blvd Kettering OH 45409-1337

Department of Veterans Affairs Financial Management System PO Box 149971 Austin TX 78714-9971

877-353-9791 512-460-5540

X

See CONTINUATION Page

RFQ for 5-Year Ordering Period IDIQ for Radioactive Isotopes, Radiopharmaceutical Kit Vials and Chromatography Supplies for the Ann Arbor VA and Toledo VA Clinic.

POP: 10/1/206 - 9/30/2031

See Price/Cost Schedule.

Please Note: There is an excel spreadsheet attached that vendor is required to fill out along with the RFQ document.

Complete BAA document from section D. or provide current national BAA.

All questions must be submitted by 7/30/2026 by 4:30 pm.

All Quotes are due by 8/13/2026 by 11:00 am.

Required Training:

TMS 10204 Privacy and HIPAA Focused Training TMS 10176 VA Privacy & Information Security Awareness & ROB

See CONTINUATION Page

X X

Kellie Konopinski Contracting Officer

36C25026Q0724

Table of Contents

SECTION A

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

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK

B.3 VA INFORMATION AND INFORMATION SYSTEM SECURITY AND PRIVACY

LANGUAGE FOR INCLUSION IN CONTRACTS

B.4 NARA RECORDS MANAGEMENT – ATTACHMENT (1) TO SCOPE OF WORK .. 17

B.5 PRICE/COST SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.216-18 ORDERING (AUG 2020)

C.2 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.3 52.216-22 INDEFINITE QUANTITY (NOV 2025) (DEVIATION) ALTERNATE II

(NOV 2025)

C.4 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.5 52.240-91 SECURITY PROHIBITIONS AND EXCLUSIONS (NOV 2025)

(DEVIATION)

C.6 52.222-90 ADDRESSING DEI DISCRIMINATION BY FEDERAL CONTRACTORS

(DEVIATION APR 2026)

C.7 52.223-7 NOTICE OF RADIOACTIVE MATERIALS (NOV 2025) (DEVIATION)

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

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 BUSINESS ASSOCIATE AGREEMENT

D.2 ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.2 52.216-1 TYPE OF CONTRACT (NOV 2025) (DEVIATION)

E.3 52.219-1 SMALL BUSINESS PROGRAM REPRESENTATIONS (NOV 2025)

(DEVIATION)

E.4 52.225-6 TRADE AGREEMENTS CERTIFICATE (FEB 2021)

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

E.6 52.240-90 SECURITY PROHIBITIONS AND EXCLUSIONS REPRESENTATIONS

AND CERTIFICATIONS (NOV 2025) (DEVIATION)

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

1998)

E.8 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (OCT 2025) (DEVIATION)

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: ___________________________________

POC: ______________________________

PHONE: ______________________________

EMAIL: ______________________________

b. GOVERNMENT: Contracting Officer 36C250

Kellie Konopinski

734-222-4330

Kellie.Konopinski@va.gov

Department of Veterans Affairs

Network Contracting Office 10

Suite 210

3140 Governors Place Blvd

Kettering OH 45409-1337

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

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

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly

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

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

AMENDMENT NO DATE

B.2 STATEMENT OF WORK

Nuclear Medicine Radioactive Isotopes, Radiopharmaceutical Kit Vials, and Chromatography Supplies

1.0 Summary:

The VA Ann Arbor Healthcare System (VAAAHS) has a requirement for radiopharmaceuticals and radioactive sources for the nuclear medicine department. Due to the terms of United States Pharmacopoeia USP<825>, the medical center can no longer compound radioisotopes in the facility’s existing hot lab. It is necessary to obtain these products and services that are both vital and critical to patient care from an outside nuclear pharmacy. Contractor shall furnish radioactive isotopes, vial kits, and chromatography supplies for diagnostic imaging, therapies, research, and equipment quality control in accordance with the terms and conditions of this contract for the period of October 1, 2026, through September 30, 2031.

2.0 Requirements:

1. Contractor must be licensed by the U.S. Nuclear Regulatory Commission (USNRC), or a State with a formal Agreement with the USNRC that allows the State to regulate radioactive materials (Licensee) and be regularly established in the business of providing radiopharmaceuticals at the scale and frequency necessary to meet this requirement. The Radiopharmaceuticals must be shipped from the Licensee directly to locations of use requested by the VAAAHS.

2. Contractor/licensee shall meet all applicable USNRC, Department of Veterans Affairs National Health Physics Program (NHPP), Department of Transportation (DOT), Food and Drug administration (FDA), State, and Federal requirements, rules, and/or regulations related to the supply of Radiopharmaceuticals.

3. In accordance with Presidential/White House request for preferential procurement made to the Veterans Health Administration (VHA), >90% of Technetium-99m unit doses will be derived from Non-High Enriched Uranium- 235 (Non-HEU) sources, also known as Low Enriched Uranium-235 (LEU) sources. Pricing should include cost for both LEU and non-LEU derived Technetium-99m to account for those instances where product availability becomes limited.

4. The contractor will meet all radiopharmaceutical requirements for VAAAHS (both the Ann Arbor VAMC and VA Toledo Outpatient Clinic locations) in unit dose form. (See Schedule of Supplies/Services)

5. The contractor will provide Non-Highly Enriched Uranium radiopharmaceuticals whenever possible in accordance with the VHA Memorandum dated 01-03-2014 from the VA Under Secretary for Health. (See Attachment A)

6. The contractor shall provide radioactive sealed sources necessary for patient care and quality control (See Schedule of Supplies/Services).

7. The contractor shall provide radioactive material in the form requested by

VAAAHS for equipment quality control testing.

8. All packages containing radioactive material must be labeled and shipped in accordance with Title 49, Code of Federal Regulations (CFR) Part 172 and 173, and Title 10, CFR Part 71.

9. Contractor/licensee shall perform all quality control procedures as required by Federal, and when applicable, State regulatory agencies. Quality Control results will be furnished to VAAHS upon request.

10. Contractor/supplier shall abide by Title 10, CFR, which states: A Licensee may use for medical purposes only:

(a) By-product material or cyclotron produced materials manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to the regulations in Title 10, CFR, Part 35 and/or the equivalent regulations of an Agreement State.

(b) Reagent kit that has been manufactured, labeled, packed and distributed in accordance with approval by the NRC pursuant to Title 10 CFR 32.72 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use.

11. The contractor shall provide Radiopharmaceuticals during standard hours of care

Monday through Friday from 0630 (AM EST) until 1600 hours (4:00 PM EST), not including Federal holidays. The contractor shall provide after-hours coverage 24 hours per day, Saturday and Sunday, and on Monday through Friday from 1600 (4:00PM EST) until 0630 hours including Federal holidays. Radioactive sealed sources will be delivered during normal business hours Monday through Friday from 0630- 1600 (4:00 PM EST).

Federal holidays include the following:

New Year’s Day Martin Luther King Day Presidents Day Memorial Day Juneteenth

Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

Federal holidays also include any day specifically declared by the President of the United States as a holiday.

NOTE: If the holiday falls on a Saturday, it will be officially observed on the Friday before the holiday. If the holiday falls on a Sunday, it will be officially observed on the Monday following the holiday.

12. For the placement of orders, the contactor will be contacted by staff nuclear medicine technologists assigned to the nuclear medicine department at Ann Arbor VA Medical Center and VA Toledo Outpatient Clinic.

13. All routine orders for Radiopharmaceutical doses will be placed via phone, fax, or internet with the contractor one day before they are needed and prior to the VA Nuclear Medicine Clinic close of business. The order shall include specified activities of doses, calibration times, and patient name. The contractor shall deliver the first run of ordered Radiopharmaceutical doses to Ann Arbor VA Medical Center, 2215 Fuller Road, Ann Arbor, MI 48105, Nuclear Medicine Clinic, Room D764 and Room D734 between 0630-0645 (AM EST). The Contractor shall deliver the first run of ordered Radiopharmaceutical doses to the Toledo Outpatient Clinic, 1200 S Detroit Ave, Toledo, OH 43614 Toledo Nuclear Medicine Clinic Room 1-310 between 0730-0745 (AM EST) on the day specified to ensure proper inventory and receipt of the shipment is done by qualified personnel. The contractor shall deliver a subsequent run of ordered radiopharmaceuticals by 1130 (EST) and, if necessary, shall deliver a third run prior to the closure of business for all add-on procedures ordered.

14. Online ordering from vendor website will require product selection list to only include items listed in contract as selectable. This is a requirement to prevent unauthorized purchased commitments.

15. Same-Day Add-on Delivery of routine non-Emergent radiopharmaceutical shall be received at Ann Arbor VAMC or TOPC facilities up to 150 minutes after the order is placed during normal business hours if approved by VAAAHS authorized personnel.

16. All emergency STAT orders or after-hour orders of radiopharmaceutical doses shall be placed by staff Nuclear Medicine Technologist on an emergency need basis. The contractor shall deliver all emergency STAT orders of Radiopharmaceuticals within 90 minutes of the Radiopharmaceutical doses being ordered to the Nuclear Medicine Clinic, Room D764, D734, or Toledo Room 1- 310.

17. The contractor shall calibrate all Radiopharmaceutical doses to ensure proper activity ranges of +/- 10 percent of the specified ordered dose based on specific requirements provided by Nuclear Medicine Clinic based on guidelines outlined in 10 CFR Part 35.

18. Radiopharmaceutical Returns for Credit: Ann Arbor VAMC and TOPC facilities require the Contractor to accept returns for full credit toward future orders under the following conditions:

(a) Product(s) ordered or shipped in error.

(b) Product(s) damaged in shipment

(c) Concealed shipping damages

(d) Recalled product(s)

(e) Outdated products in unopened, original container.

19. The contractor shall be able to work within NMIS, the current Nuclear Medicine management program at Ann Arbor VAMC and TOPC. This shall allow for the receipt, inventory and proper documentation of Radiopharmaceutical doses dispensed. The contractor provided packaging slip of received supplies shall have a compatible barcode that relays correct dispensary information of product into the NMIS system for inventory receipt. This shall include but not limited to Radioactive Isotope and or Product Name, Calibrated Activity, Calibration date/time, Expiration date/time, Volume, and RX number and or Lot Number.

20. The contractor shall ensure that all Radiopharmaceutical doses provided are compounded and calibrated by or under the supervision of a certified Nuclear Medicine Pharmacist.

21. The contractor shall provide courier service that is in accordance with DOT, USNRC and other applicable regulating authorities enabling the delivery of all Radiopharmaceuticals. All couriers shall be licensed. Couriers shall submit all paperwork required for access to Ann Arbor VA Medical Center and TOPC. The contractor shall be responsible for the removal of carrier containers and “empty” non-radioactive shielded carriers (lead pigs, lead vial containers, etc.) from the clinic within 72 hours of delivery.

22. All couriers will deliver product through the facility via approve route by facility VA

Police. Approved route information will be provided by VA Ann Arbor Nuclear Medicine Department or Radiation Safety Officer.

23. The contractor shall notify Ann Arbor VAMC Nuclear Medicine Clinic and TOPC Nuclear Medicine Clinic immediately should the inability arise to provide Radiopharmaceutical doses. The inability to provide radiopharmaceuticals that will delay patient care gives the Ann Arbor VAMC and TOPC authority to purchase required radiopharmaceuticals from a different vendor.

24. The contractor shall provide any training or education required to meet commercial standards related to use of radiopharmaceuticals to all staff Nuclear Medicine Technologists stationed at Ann Arbor VAMC and TOPC.

25. At end of each ordering period, the contractor shall supply the VA with a report of totals for each line item supplied/delivered during that period of performance.

SCHEDULE OF SUPPLIES AND SERVICES

The Department of Veterans Affairs Ann Arbor Health Care System for the Ann Arbor VA Medical Center and the Toledo Outpatient Clinic, Nuclear Medicine Service requires the contractor/licensee to provide radiopharmaceuticals, and any needed quality check/QC/etc. sources to be used with Radioassay, Radiopharmacy, Gamma Camera/SPECT, SPECT/CT, and PET/CT imaging systems within Ann Arbor VAMC and

TOPC.

Radiopharmaceutical

Estimated Quantity Total

UNIT OF

MEASURE

Ann Arbor Toledo

Tc99m-Sestimbi UD 2,700 EA 2,000 700 Tc99m-Tetrofosmin (MYOVIEW) 50 EA 40 10 Tc99m-Pentetate (DTPA) 50 EA 40 10 Tc99m- Mertiatide (MAG3) 35 EA 30 5 Tc99m-Medronate (MDP) 250 EA 235 15 Tc99m-Oxidrontate (HDP) 40 EA 35 5 Tc99m- Albumin Aggregated (MAA) 50 EA 45 5 Tc99m-Albumin Aggregated Reduced Particles

(MAA) 20 EA 15 5

Tc99m- Sulfur Colloid 100 EA 90 10 Tc99m- Filtered Sulfur Colloid 100 EA 96 4 Tc99m-Mebrofenin 35 EA 30 5 Tc99m-Pyrophosphate (PYP) 45 EA 40 5 Tc99m Exametazime (Ceretec) WBC 2 EA 1 1 Tc99m DTPA Renal 2 EA 1 1 Tc99m Bicisate 2 EA 1 1 In-111 Pentreotide 1 EA 1 0 In-111 White Blood Cells (WBC) 2 EA 1 1 In-111 Oxine 5 EA 3 2 I-123 200uCi Capsule 2 EA 1 1 I-123 Andreview (MIBG) 2 EA 1 1 I-123 Ioflupane 55 EA 50 5 I-131 Diagnostic Capsule 20 EA 15 5 I-131 Therapeutic Capsule (mCi) 450 EA 450 1 Sodium Pertechnetate (Tc99m)(mCi) 30,000 EA 29,000 1,000 F-18 Fluorodeoxyglucose (FDG) 1,250 EA 1,250 0

Ga-68 Dotatate (Netspot) 40 EA 40 0 Albumin Aggregated (MAA) Kit 4 EA 3 1 Medronate (MDP) Kit 6 EA 4 2 Mebrofenin Kit 6 EA 5 1 Pyprophosphate (PYP) Kit 200 EA 150 50 Pentetate (DTPA) Kit 4 EA 3 1 Ultratag RBC Kit 40 EA 35 5

WBC BLOOD KIT 2 EA 1 1

Acetone 2 EA 1 1 20% NaCl 3 EA 2 1 QC STRIP RED 150-001 (50 Strip Pack) 2 EA 1 1 QC STRIP BLACK 150-005 (50 Strip Pack) 2 EA 1 1 QC STRIP ORANGE 150-122 (50 Strip Pack) 2 EA 1 1 QC STRIP Light Blue (50 Strip Pack) 2 EA 1 1 Sterile Water 10ml 28 EA 20 8 Kinevac 45 EA 35 10 Co-57 Flood Source (Flexible) 10/mCi – Model PF24R-050-10M-NC, 16.5”x24”, Rectangle 2 EA 1 1 Co-57 Flood Source (Flexible) 20/mCi- Model PF24R-050-20M-NC, 16.5”x24”, Rectangle 2 EA 1 1 Cs-137 Dose Cal. Vial Ref. Source- Model Number NMC-350, 200uCi Reference/Vial Source 2 EA 1 1 Ba-133 Dose Cal. Vial Ref. Source- Model Number NMC-358, 250uCi Reference/Vial Source 2 EA 1 1 Cs-137 Rod Ref. Source- Model Number 0975- 137R, 0.5uCi, 5” Rod Source 2 EA 1 1 Eu-152 Rod Ref. Source - Model Number 0975- 152R, 0.5uCi, 5” Rod Source 2 EA 1 1 *Tc99m-Tilmanocept (Lymphoseek) 16 EA 12 4 *F-18 Florbetaben (Neurceq) 120 EA 120 0 *F-18 Flortaucipir (Tauvid) 10 EA 10 0 *F-18 Florbetapir (Amyvid) 120 EA 120 0 *F-18 Flurpiridaz (Flyrcado) 200 EA 200 0

* Items marked with (*) are preferred for vendor offering availability but not mandatory.

All Flood, Vial, and Rod Source model/part numbers were referenced from Pinestar Technology Inc. https://www.pinestar.com/

Vendors are encouraged to list any additional line items they can provide, including new to market products and radiotracers that may provide a contingency source for other Nuclear Medicine Service modalities.

https://www.pinestar.com/

B.3 VA INFORMATION AND INFORMATION SYSTEM SECURITY AND

PRIVACY LANGUAGE FOR INCLUSION IN CONTRACTS

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

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

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

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

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

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

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

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

k. Notwithstanding the provision above, the contractor shall not release VA records protected by Title 38 U.S.C. § 5705, Confidentiality of medical quality-assurance records and/or Title 38 U.S.C. § 7332, Confidentiality of certain medical records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse or infection with Human Immunodeficiency Virus (HIV). If the contractor is in receipt of a court order or other requests for the above-mentioned information, the contractor shall immediately refer such court order or other requests to the VA CO for response.

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

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

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

o. Any media, such as paper, magnetic tape, magnetic disks, solid state devices or optical discs that is used to store, process, or access VA information that cannot be destroyed shall be returned to VA.The contractor shall hold the appropriate material until otherwise directed by the Contracting Officer’s Representative (COR) or CO. Items shall be returned securely via VA-approved methods. VA sensitive information must be transmitted utilizing VA-approved encryption tools which are validated under FIPS 140-2 (or its successor) and NIST 800-52. If mailed, the contractor shall send via a trackable method (USPS, UPS, FedEx, etc.)

and immediately provide the COR/CO with the tracking information. Self-certification by the contractor that the data destruction requirements above have been met shall be sent to the COR/CO within 30 business days of termination of the contract.

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

3. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS. 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.

(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) 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].

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.

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 – N/A

7. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE OR USE – N/A

8. SECURITY AND PRIVACY CONTROLS COMPLIANCE TESTING, ASSESSMENT AND

AUDITING – N/A

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

ANTI-TAMPERING. This entire section applies when the acquisition involves any product (application, hardware, or software) or when section 6 or 7 is included.

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

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

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

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

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

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

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

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

10. VIRUSES, FIRMWARE AND MALWARE. This entire section applies when the acquisition involves any product (application, hardware, or software) or when section 6 or 7 is included.

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

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

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

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

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

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

11. CRYPTOGRAPHIC REQUIREMENT – N/A

12. PATCHING GOVERNANCE – N/A

13. SPECIALIZED DEVICES/SYSTEMS (MEDICAL DEVICES, SPECIAL PURPOSE

SYSTEMS, RESEARCH SCIENTIFIC COMPUTING) – N/A

14. DATA CENTER PROVISIONS – N/A

B.4 NARA RECORDS MANAGEMENT – ATTACHMENT (1) TO SCOPE OF WORK

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. VA Ann Arbor Healthcare Systems and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VA Ann Arbor Healthcare Systems or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to VA Ann Arbor Healthcare Systems. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to VA Ann Arbor Healthcare Systems control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts.

The Contractor (and any sub-contractor) is required to abide by Government and VA Ann Arbor Healthcare Systems guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VA Ann Arbor Healthcare Systems policy.

8. The Contractor shall not create or maintain any records containing any non-public VA Ann Arbor Healthcare Systems information that are not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The VA Ann Arbor Healthcare Systems owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VA Ann Arbor Healthcare Systems shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #3873736, Records Management for Records Officers and Liaisons. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

B.5 PRICE/COST SCHEDULE

Vendor must complete all rows that are highlighted on the attached document “S02 Line Items for Vendor to Complete”.

SECTION C - CONTRACT CLAUSES

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text.