36C24924Q0278_1.docx

36C24924Q0278

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

36C24924Q0278 08-05-2024 Doug Huddy 615-225-3418 08-13-2024 12:00

CDT

Department of Veterans Affairs Network Contracting Office 9 (90C)

NCO 9

1639 Medical Center Parkway, Suite 204 Murfreesboro

TN

37129 X 325412 Net 30 N/A X Robley Rex VAMC 800 Zorn Avenue Louisville

KY

40206 Network Contracting Office 9 Department of Veterans Affairs Network Contracting Office (90C) 1639 Medical Center Parkway Suite 204 Murfreesboro

TN

37129

90C FSC e-Invoicing Payment http://www.fsc.va.gov/fsc/einvoice.asp Invoice Setup Information 1-877-489-6135 Invoice must be submitted electronically

Setup 1-877-489-6135 See CONTINUATION Page This solicitation is issued as a Request for Quotations in accordance with FAR Part 13. VA Medical Center – Louisville seeks quotes for the provision of radiopharmaceuticals in accordance with the below Statement of Work.

Comparative Evaluations of quotes will be performed IAW FAR 13.106-2(b), best value using price and other factors.

This RFQ will result in one firm-fixed price Indefinite Delivery/Indefinite Quantity contract.

Questions regarding this solicitation are due to Doug Huddy via email only at douglas.huddy@va.gov.

Questions are due no later than 8/8/2024 at 12: p.m., CT See CONTINUATION Page X X Doug Huddy 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 36C249 Doug Huddy Department of Veterans Affairs Network Contracting Office 9 (90C)

NCO 9

1639 Medical Center Parkway, Suite 204 Murfreesboro TN 37129

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

3. INVOICES: Invoices shall be submitted in arrears:

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

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

36C24924Q0278

Page 1 of Page 1 of

ROBLEY REX VA MEDICAL CENTER STATEMENT OF WORK

RADIOPHARMACEUTICAL (ISOTOPES) SUPPLIES & SERVICES

STATEMENT OF OBJECTIVES

The Contractor will be required to provide radiopharmaceutical and associated supplies on demand to the Robley Rex Veterans Affairs Medical Center (Robley Rex VAMC). Radiopharmaceutical deliveries will include, but are not limited to the following:

1. SCOPE/DELIVERY:

1.1 Contractor will provide the Robley Rex VAMC a copy of their current radioactive material permit or license for the authorized service of a radiopharmacy. The contractor will provide updated copies when permit or license has expired.

1.2 Robley Rex VAMC Nuclear Medicine Technologists (NMT), Authorized Users (AU) or Radiation Safety Officer (RSO) will be authorized to place telephone orders for radiopharmaceuticals, sealed sources, and unsealed materials used for quality control (QC) and performing confirmatory shielding surveys.

1.3 Contractor will supply two (2) phone numbers for ordering after normal business hours. Orders shall be placed the afternoon before the required delivery date for exact quantities of each unit dose or during the business day for patients added on overnight.

1.4 Deliveries will be made to the Robley Rex VAMC, 800 Zorn Avenue, Louisville, KY, 40206-1499 or Robley Rex VAMC 4906 Brownsboro Road Louisville, KY 40222 Nuclear Medicine Hot Lab(s) during normal business hours Monday-Friday 6:30 AM - 4:30 PM. The room number(s) for the Nuclear Medicine Hot Lab(s) will be provided and updated as needed by a NMT, RSO or COR for this contract.

1.5 Four (4) free daily deliveries will be made during routine business hours defined as Monday-Friday 6:30 AM -4:30 PM (excluding holidays), are required.

1.6 Emergency orders can be placed at any time with expected delivery within one (1) hour of the order.

1.7 Deliveries made outside of normal business hours or on the weekend (Saturday/Sunday) and all Federal Holidays (or any other day specifically declared by the President of the United States to be a national holiday) shall be made by contacting the Veterans Affairs Medical Center Police for delivery to the Nuclear Medicine Hot Lab(s) for placement of the packages.

Federal Holidays:

· New Year’s Day

· Martin Luther King’s Birthday

· President’s Day

· Memorial Day

· Juneteenth Day

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving Day

· Christmas Day

1.8 Individual radiopharmaceuticals and unsealed materials used for QC and performing confirmatory shielding surveys will be provided in unit dose form. Delivered unit doses will be placed in the appropriate calibration device designed to reduce exposure from gamma emitting or beta emitting depending on primary ionizing radiation emitters of radiopharmaceutical.

1.9 Radiopharmaceuticals and sealed sources will be delivered in Department of Transportation (DOT) approved shipping containers.

1.10 Contractor shall provide evidence of DOT training for individuals making deliveries.

2. QUALITY:

2.1 Contractor shall guarantee the quality and purity of the radiopharmaceutical. Quality Control (QC) shall include the use of Federal Drug Administration (FDA) approved products for the medical use in humans with an available NDC number from the manufacturer, lot/control number, and expiration date for the product supplied.

2.2 LEU Tc99m generators will be used for applicable dose preparation.

2.3 Doses shall be prepared in a clean environment and in compliance with United States Pharmacopeia (USP) 825 compounding requirements.

2.3 Testing of material from generators will include the following: applicable pH testing, percent tag, aluminum and 99Mo breakthrough, as appropriate. Supporting documentation of all quality requirements will be provided upon request.

2.4 All radiopharmaceuticals shall be calibrated and labeled with radiopharmaceutical name, time the dose was prepared, total volume, and total activity, lot number and bar codes for tracking.

2.5 The contractor will exchange at no cost radiopharmaceutical dose(s) measuring 20% greater or less than requested for the specific time. A replacement dose will be provided within one (1) hour of contacting the contractor at no additional charge for the replacement dose.

2.6. Consultation service regarding radiopharmaceutical applications, problems, controls, etc., shall be provided twenty-four hours per day, seven days per week, upon request at no charge.

2.7 The contractor must be licensed and in good standing with the state board of pharmacy to operate a radio-pharmacy and possess a radioactive material permit/license issued by the US NRC or an agreement state for the receipt, preparation, and distribution of radiopharmaceuticals and sealed sources. Any notice of violation (NOV) issued against the contractor by licensing and/or regulatory agencies (state of Kentucky, US Nuclear Regulatory Commission (NRC), Department of Transportation (DOT), FDA, and all other agencies state or federal will be provided to the Robley Rex VAMC within 10 business days of the contractor’s receipt of the NOV.

3. WASTE REMOVAL:

3.1 Each workday, the contractor shall remove all radioactive waste generated by contractor supplied radiopharmaceuticals (to include all syringes with a sealable safety insert for return of spent doses that ensure standard precautions of the used syringe and vials and blood borne contaminants) without cost.

3.2 The Contractor will arrange return (disposal) of radiopharmaceuticals after proper decay time at RRVAMC and prepare for shipment sealed sources being replaced with sealed sources purchased under this contract in a timely manner. The contractor will provide required documentation of the sealed source to meet NRC disposal guidelines.

4. INVOICES:

4.1 The contractor will provide the Contracting Officer Representative (COR) and the Lead Nuclear Medicine Technologist a copy of invoice for review and approval. All invoices will include name of company name and address, point of contact, contract number, dates of services, purchase order number, invoice number, and an itemized listing of charges.

4.2 Contractor will submit Invoices monthly, via TUNGSTEN, Austin, Texas for online certification and payment.

5. SOFTWARE AND BAR CODE SCANNER(S):

5.1 The contractor grants the Robley Rex VAMC a nonexclusive, nontransferable license to possess and use the software package to track inventory received from contractor and QC procedures performed in Nuclear Medicine.

5.2 The software will be in machine-readable form for use on four (4) personal computer(s) located at the Robley Rex VAMC.

5.3 Robley Rex VAMC may not copy or transfer the software or license to another party. “Use” means loading onto or transmitting to the personal computer(s) and executing storing or displaying thereon.

5.4 The contractor shall deliver to the Robley Rex VAMC the licensed programs in machine readable object code form and support materials sufficient for Robley Rex VAMC’s exercise of its rights under this license. This software license shall remain in full force and effect at no charge for the term of this contract provided the Robley Rex VAMC complies with the terms and conditions of this contract.

5.5 Upon termination, for any reason, Robley Rex VAMC shall promptly return the software together with all its copies, modifications, and merged portions in any form to the contractor. The Robley Rex VAMC may not copy, reproduce, sublicense, assign or transfer this license or the software or remove any copyright or other proprietary notices form the licensed software. Any attempt to sublicense, assign, or transfer any of the rights, duties or obligations hereunder is expressly prohibited. The licensed software and all its intellectual property rights, including without limitation, patent, trademark, copyright and trade secret rights in the licensed software are and shall be the property solely of the contractor. The contractor does not warrant that the functions contained in the software will meet Robley Rex VAMC requirements or that the operation of the software will be uninterrupted or error free. The contractor warrants the disk on which the software is furnished, to be free from defects in materials and workmanship under normal use for the period of ninety days from date of delivery to the Robley Rex VAMC as evidenced by a copy of the receipt. The contractor makes no other warranties with regard to the software. The contractor expressly and specifically disclaims any warranty of merchantability or fitness for a particular purpose. The contractor entire liability and Robley Rex VAMC’s exclusive remedy shall be: (a) the replacement of any disk not meeting the contractor’s “limited warranty” and which is returned to the contractor within 90 days of the date of delivery; or (b) if the contractor is unable to deliver a replacement disk which is free of defects in materials or workmanship. The Robley Rex VAMC may terminate this agreement by returning the software to the contractor. In no event will the contractor be liable to the Robley Rex VAMC for any damages including and lost profits, lost savings, or other incidental or consequential damages arising out of the use, or inability to use such software or for any claim by any other party.

6. SITE VISIT: A site visit may be conducted prior to award of the contract.

II. PRICING SCHEDULE

Contractor will provide the Robley Rex Veterans Affairs Medical Center, Louisville, KY, with pricing for the following items. The quantities are the estimated for a 12-month period.

Base Period: Period of Service October 1, 2024 – September 30, 2025

Total Estimated Contract Price (Base Year): $_________________

Ordering Period #2: Period of Service October 1, 2025 – September 30, 2026

Total Estimated Contract Price (Ordering Period 2): $_________________

Ordering Period #3: Period of Service October 1, 2026 – September 30, 2027

Total Estimated Contract Price (Ordering Period #3): $_________________

Ordering Period #4: Period of Service October 1, 2027 – September 30, 2028

Total Estimated Contract Price (Ordering Period #4): $_________________

Ordering Period #5: Period of Service October 1, 2028 – September 30, 2029

Products (including software, licenses)

OP 5

Total Estimated Contract Price (Ordering Period #5): $_________________

III. TERM OF CONTRACT

This contract is effective for the base period October 1, 2024 thru September 30, 2025 with four additional ordering periods, 10-1-25 through 9-30-29. This contract is subject to the availability of VA funds.

IV. DEFINITIONS

Terms used in this contract shall be interpreted as follows unless the context expressly requires a different construction and/or interpretation. In case of a conflict in language between the definitions and other sections of this contract, the language in this section shall govern.

1. Contracting Officer (CO) - The person executing this contract on behalf of the Government with the authority to enter into and administer contracts and make related determinations and findings.

2. Contracting Officer’s Technical Representative (COR) - A person appointed by the CO to take necessary action to ensure the contractor performs in accordance with and adheres to the specifications contained in the contract and to protect the interest of the Government. The COR shall report to the CO promptly any indication of non-compliance in order that appropriate action can be taken.

3. Veterans Health Administration (VHA) - The central office for administration of the VA medical centers throughout the United States. The VHA is located in Washington, DC.

4. Veterans Integrated Services Network (VISN) - The regional oversight for the VA Medical Centers in Memphis, TN, Tennessee Valley Healthcare System (Murfreesboro and Nashville), Louisville, KY, Lexington, KY, Huntington, West Virginia and Mt. Home, TN. The VISN office is located at 1801 West End Avenue, Suite 1100, Nashville, TN 37203.

V. QUALITY REQUIREMENTS

Contractor shall guarantee the quality of the radiopharmaceutical. Quality Control (QC) shall include pH testing, percent tag, alumina and 99Mo breakthrough as appropriate. Quality Control shall be performed on each agent dispensed. Complete documentation of QC results will be provided upon request. All radiopharmaceuticals shall be calibrated and labeled with concentration, time, total volume, and total activity. Consultation service regarding radiopharmaceutical applications, problems, controls, etc. shall be provided upon request at no charge.

On an annual basis, the Contractor will provide documentation demonstrating compliance with state and regulatory requirements for a radiopharmacy to the Radiation Safety Officer.

VI. CREDENTIAL REVIEWS/PRIVILEGING

Not Applicable

VII. KEY PERSONNEL

1. The Contractor will designate one person who can be contacted for any problems or issues that arise in the performance of this contract to the Robley Rex VAMC with a phone number. The Robley Rex VAMC will also designate a contact person.

2. The contractor must identify key personnel proposed to provide the required services and their qualifications upon award of contract and on an annual basis thereafter. The contractor cannot change key personnel without VAMC approval.

VIII. PATIENT RIGHTS AND SAFETY

The Robley Rex VAMC is not responsible or liable for any unsafe condition caused by the Contractor or Veteran. The Contractor will have evidence of implementation of the Joint Commission National Patient Safety Goals as applicable.

IX. CONTINUUM OF CARE

Individual radiopharmaceuticals will be provided in unit dose form and will be delivered at the request of the Robley Rex VAMC.

X. QUALITY ASSURANCE SURVEILLANCE PLAN

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. The performance standards are as follows:

On call requests will be made to the designated NMD Hot Lab within one (1) hour of the request.

Contractor will ensue compliance with US NRC and DOT regulations and requirements for the delivery and return of products to the designated NMD Hot Labs.

On call requests will be made to the NMD Hot Lab within one (1) hour of the request

NMD will notify the Radiology Manager of Manager of on call requests exceeding one (1) hour in delivery time.

Radiology Manager will report to COR for review with CO.

Failure to follow US NRC and DOT Regulation and requirements for the delivery and return of product to and from designated NMD Hot Labs and provide on call delivery’s in may result in unfavorable contractor performance evaluation, which could result in not ordering IAW subsequent ordering periods.

Radiopharmaceutical consultation services related to products in the contract Contractor will guarantee that all radiopharmaceutical doses are delivered according to specific request.

Radiopharmaceutical consultation services will be immediately available by telephone, 24hrs/day, 7 days per week.

Failure to deliver specific requested items and provide consultation services may result in unfavorable contractor performance evaluation, which could result in not ordering IAW subsequent ordering periods.

On an annual basis, the Contractor will provide any NOV’s received during contract period and on an annual basis current documented information of USP 797 and/or 885 Compounding, a copy of their current KY RHB Radioactive Materials (RAM) License. The current RAM License will be received at VAMC before previous license expires. The Contractor will submit the RAM License to the COR for posting in the NMD.

and failure by the contractor to provide current documentation of USP 797 and/or 885 compounding and KY RHB RAM License

Failure to possess documentation may result in unfavorable contractor performance evaluation, which could result in not ordering IAW subsequent ordering periods .

XI. ENVIRONMENT OF CARE

Each workday, the contractor shall remove all radioactive waste generated by contractor (to include all syringes and vials). Safe transport of the waste is the responsibility of the contractor. Contractor must adhere to OSHA guidelines regarding blood borne pathogens, DOT regulations, Board of Pharmacy regulations pertinent to radiopharmaceuticals, and NRC requirements regarding radioactive materials

XII. INFORMATION MANAGEMENT SECURITY

1. GENERAL

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

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

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

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

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

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

3. VA INFORMATION CUSTODIAL LANGUAGE

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

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

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

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

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

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

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

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

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

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

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

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

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

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

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

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

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

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

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

g. The contractor/subcontractor agrees to:

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

i. The Systems of Records (SOR); and

ii. The design, development, or operation work that the contractor/subcontractor is to perform;

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

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

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

a. “Operation of a System of Records” means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.

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

k. “System of Records” means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying assigned to the individual.

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

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

n. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the contractor shall provide written notice to the VA that the patch has been validated as not affecting the Systems within 10…