C03 36C26025P0217.pdf

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

496-25-1-287-0011

36C26025P0217

EFFECTIVE: 12-10-2024

36C26025Q0077

Amy Kuczajda 208-429-2018

NCO 20 Network Contracting Office

ATTN: V4CONT

1601 E. Fourth Plain Blvd Bldg.17, Suite B428 Vancouver WA 98661

X

541519

$34 Million

Net 30

N/A

Department of Veterans Affairs VISN 20 - multiple locations See Page 7 for details

Portland OR 97239

NCO 20 Network Contracting Office

ATTN: V4CONT

1601 E. Fourth Plain Blvd Bldg.17, Suite B428 Vancouver WA 98661

4FM56

RIVERAIN TECHNOLOGIES, INC.

RIVERAIN MEDICAL

3130 S TECH BLVD

MIAMISBURG OH 45342-4882

NGCJXHLWNDU3

Tungsten Network

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971

See CONTINUATION Page

Riverain ClearRead Lung Vomputer Aided Detection (CAD) System software and maintenance throughout VISN 20.

Period of Performance:

12/10/2024 - 12/09/2025 with 4 Option Years

Reference Obligation Number 496-C55014 on all invoices submitted for payment via Tungsten Network.

Facility POC: Virginia (Ginny) Hall or Marie Reising Virginia.Hall3@va.gov or Marie.Reising@va.gov

Contracting POC: Amy Kuczajda at Amy.Kuczajda@va.gov

$37,203.00 See CONTINUATION Page x X

Amy Kuczajda

VA-VHA-RPOW-2023-0056

12/09/2024

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PERFORMANCE WORK STATEMENT

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ACCOUNTING AND APPROPRIATION DATA

SECTION C - CONTRACT CLAUSES

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

AND COMMERCIAL SERVICES (NOV 2023)

C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ... 29

C.4 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.5 VAAR 852.239-76 INFORMATION AND COMMUNICATION TECHNOLOGY

ACCESSIBILITY (FEB 2023)

C.6 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ... 31

C.7 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.8 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAY 2024)

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: Riverain Technologies, Inc.

Chris Michel 315-415-7001 cmichel@riveraintech.com

b. GOVERNMENT: Contracting Officer 36C260 Amy Kuczajda NCO 20 Network Contracting Office

ATTN: V4CONT

1601 E. Fourth Plain Blvd Bldg.17, Suite B428 Vancouver WA 98661

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] Annually

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 PERFORMANCE WORK STATEMENT

ClearRead Support

VISN 20

1. Contract Title. VISN 20 ClearRead Support

2. Background.

2.1 The VA Northwest Health Network, Veterans Integrated Service Network (VISN) 20, is responsible for providing health care to Veterans in the states of Alaska, Washington, Oregon, most of the state of Idaho, and one county each in Montana and California. VISN 20 encompasses 135 counties which cover approximately 23% of the United States land mass; 17% of which are classified as health professional shortage areas. 67% of these same counties had a 2001 per capita income below $25,000. There are approximately 1.2 million Veterans living in the Pacific Northwest and Alaska, 18% of whom received VA services.

2.2 This procurement is for software support and software maintenance for ClearRead

Xray Bone Suppression and Detection and ClearRead CT Vessel Suppression and Detection.

2.2.1 The ClearRead xray bone suppression and detection application increases the clarity of chest X-rays by suppressing bone on the digital image. The resulting bone suppressed image can be displayed within the existing patient file and viewed on any PACS viewer. ClearRead Xray Detect is a computer-aided detection (CAD) system that processes AP/PA chest x-rays and identifies regions of interest that require further examination by a radiologist, by placing a scalable marker on a copy of the original chest X-ray. It can be used with any vendor’s x-ray device and is installed on customer’s on-premise server.

2.2.2 ClearRead CT Vessel Suppression and Detection provides efficiency and accuracy for the detection, measurement and characterization of solid, part-solid and ground glass nodules. These ClearRead software applications can be used with any vendor’s CT device and are supported and installed on the VA’s on-premise servers.

3. Applicable Documents. In performance of the tasks associated with this Performance

Work Statement, the Contractor shall comply with the following:

3.1 44 U.S.C. § 3541, “Federal Information Security Management Act (FISMA) of 2002

3.2 FIPS Pub 201, “Personal Identity Verification of Federal Employees and Contractors”

March 2006

3.3 5 U.S.C. § 552a, as amended, “The Privacy Act of 1974”

3.4 42 U.S.C. § 2000d “Title VI of the Civil Rights Act of 1964”

3.5 VA Directive 0710, “Personnel Suitability and Security Program,” September 10,

3.6 VA Directive 6102, “Internet/Intranet Services,” July 15, 2008

3.7 36 C.F.R. Part 1194 “Electronic and Information Technology Accessibility

Standards,” July 1, 2003

3.8 Office of Management & Budget (OMB) Circular A-130, “Management of Federal

Information Resources,” November 28, 2000

3.9 32 C.F.R. Part 199, “Civilian Health and Medical Program of the Uniformed Services

(CHAMPUS)”

3.10 An Introductory Resource Guide for Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule, October 2008

3.11 Sections 504 and 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998

3.12 Homeland Security Presidential Directive (12) (HSPD-12)

3.13 VA Directive 6500, “Information Security Program,” August 4, 2006

3.14 VA Handbook 6500.6, “Contract Security,” March 12, 2010

3.15 Program Management Accountability System (PMAS) portal (reference PWS

References – Technical Library at https://www.voa.va.gov/)

4. Scope. ClearRead x-ray and CT applications may be used at any VISN 20 site. This procurement scope includes software licenses, software maintenance, support, application updates, security updates, and configuration and installation assistance as listed in the requirements below.

5. Requirements.

5.1 Contractor is to provide support such that ClearRead X-Ray and ClearRead CT meet the following specifications:

5.1.1 Unlimited on-line, phone, and e-mail technical support within the timeframes listed in Hours of Support (paragraph 8) below.

5.1.2 Installation support on VA server as follows:

5.1.2.1 The input images may be derived from the modalities and acquisition systems from any vendor outlined below and output images are sent to one or more DICOM storage devices. All image transfer protocols are compliant with the DICOM 3.0 standards.

5.1.2.2 Supported Input Image Devices:

5.1.2.2.1 Computed Tomography – CT

5.1.2.2.2 Digital X-Ray – DX

5.1.2.2.3 Computed Radiography – CR

5.1.2.2.4 Secondary Capture digitized chest x-ray films - SC

5.1.2.3 Supported Destination Device Storage Formats:

5.1.2.3.1 Output images are in DICOM Secondary Capture Image Storage format.

5.1.3 Configuration support:

5.1.3.1 Configure the Riverain device on the site’s network to accept and store DICOM images with all intended DICOM modalities and PACS.

5.1.3.2 Test that the Riverain device can accept images from all modalities configured to send images to the Riverain device.

5.1.3.3 Test that the Riverain device can deliver ClearRead derived images to all intended PACS.

5.1.3.4 Assist site’s onsite resources with configuring the appropriate PACS/modalities to automatically send all Chest CT studies to the Riverain device.

5.1.3.5 Configure the Riverain device’s image filters to discard all scout, sagittal, and decubitus series.

5.1.3.6 Assist customer’s onsite resources with configuring the PACS workstation hanging protocols to display images according to the needs of the Radiologists.

5.1.3.7 Monitor the throughput to assure that the filters are working correctly.

5.1.3.8 As required, create site specific image filtering or configuration to achieve seamless workflow.

5.1.4 Post Installation Testing: Test configuration to assure images from all DICOM devices can be accepted and processed and that the ClearRead server can send processed images to PACS.

5.1.5 Typical Performance:

5.1.5.1 Typical processing time for one CT series is 270 seconds. (4.5 minutes).

5.1.5.2 Typical processing time for one X-Ray series is 20 seconds.

5.1.5.3 99.5% uptime guarantee during agreed upon hours/days of use exclusive of planned maintenance, updates, upgrades, and losses of power.

5.1.6 Provide on-site and/or remote IT, PACS and/or HTM support for configuration and testing. Provide clinical on-site and/or remote clinical applications training.

5.1.7 Test configuration to assure images from all DICOM devices can be accepted and processed and that the ClearRead server can send processed images to

PACS.

5.1.8 Contractor shall provide support for the projected annual study volumes listed in Table 1. Note that study volumes increase as existing support agreements for Boise, Puget Sound, Spokane, White City, Walla Walla, Roseburg expire:

Table 1: Annual study volume Contract Period CT XR Base Year 10,001 16,000 Option Year 1 (1) 17,751 16,400 Option Year Two (2) 29,795 16,800 Option Year Three (3) 30,540 17,230 Option Year Four (4) 31,304 17,661

6. Period of Performance. The period of performance (Table 2) shall be one (1) twelve

(12) month base period plus, four (4) additional twelve (12) month option periods for all sites listed in Table 2.

Table 2: Period of Performance

Contract Period and Site Period of Performance Base Year December 10, 2024 – December 9, 2025 Option Year 1 (1) December 10, 2025 – December 9, 2026 Option Year Two (2) December 10, 2026 – December 9, 2027 Option Year Three (3) December 10, 2027 – December 9, 2028 Option Year Four (4) December 10, 2028 – December 9, 2029

7. Place of Performance. Contract performance shall take place at the contractor’s location(s) and/or the locations listed in Table 3. All travel shall be incorporated into the price schedule for the contract. No travel costs will be reimbursed by VA.

Table 3: VISN 20 Facility Locations Facility (VAMC/HCS) Address Boise VA Medical Center 500 Fort Street Boise, ID 83702

Roseburg Healthcare System 913 NW Garden Valley Blvd Roseburg, OR 97471

Portland Healthcare System 3710 SW US Veterans Hospital Road Portland, OR 97239-2999

VA Puget Sound Health Care System 1660 South Columbian Way Seattle, WA 98108-1597

Walla Walla Jonathan M. Wainwright Memorial VA Medical Center

77 Wainwright Drive Walla Walla, WA 99362

VA Spokane Medical Center N. 4815 Assembly Street Spokane, WA 99205

VA Southern Oregon Rehabilitation Center and Clinics

8495 Crater Lake Highway White City, OR 97503

8. Hours of Coverage.

8.1 Four hour or less telephone response during regular (12-hour) business hours

8.2 Four hour or less telephone response during regular (12 hour) business hours

8.3 Off-hours telephone support requests will be responded to next day within one hour of normal business hours start.

8.4 Off-hours email requests will be responded to next day within four hours of normal business hours

8.5 Remote technical support via VPN or other secure connection during normal business hours (at least 12 hours)

8.6 24 x 7 answering service

8.7 On-site support if required

9. Invoicing. Invoices shall be submitted electronically via the Financial Services Center

Mandatory Electronic Invoice System, on a monthly basis for implementation tasks and an annual basis for license and maintenance tasks. Invoices must include, at a minimum, the following information: Contractor name, purchase order number, period of service the billing covers, and a list of equipment items covered during the stated period of performance. This requirement is in accordance with VARR Clause 852.232-72 Electronic Submission of Payment Requests: http://www.fsc.va.gov/einvoice.asp.

Electronic payments are net 30 days.

10. Security Requirements. All contractor employees are subject to the same level of investigation as VA employees who have access to VA sensitive information or access to VA facilities. The background investigation includes the following requirements: 1) Completed documentation 2) Fingerprints 3) Completion of OPM’s e-QIP Questionnaire.

The Contractor is required to fulfill all of the security requirements. The Contractor, upon completion of fingerprinting, and an initial suitability determination, may be authorized tentative access to start the performance period of the contract, but only on condition of completion of all security requirements. This requirement is applicable to all subcontractor personnel requiring the same access.

11. Access to VA Information and VA Information Systems.

11.1 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 this contract.

11.2 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.

11.3 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.

11.4 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.

11.5 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.

12. VA Information Custodial Language

12.1 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).

12.2 VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor's information systems or media storage systems in order 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 in compliance with VA directive requirements.

12.3 Prior to termination or completion of this contract, contractor/ subcontractor must not destroy information received from VA, or gathered/ created by the contractor in the course of 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.

12.4 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.

12.5 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.

12.6 If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient 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.

12.7 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.

12.8 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.

12.9 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.

12.10 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.

12.11 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.

12.12 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.

13. Information System Design and Development.

13.1 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.

13.2 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.

13.3 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.

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

13.5 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.

13.6 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.

13.7 The contractor/subcontractor agrees to:

13.7.1 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:

13.7.1.1 The Systems of Records (SOR); and

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

13.7.2 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

13.7.3 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.

13.7.4 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.

13.7.4.1 "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.

13.7.4.2 "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

13.7.4.3 "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 particular assigned to the individual.

13.8 The vendor 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, hotfixes, 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 vendor anywhere in the Systems, including

Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

13.9 The vendor 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 3 days.

13.10 When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within 3 days.

13.11 All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.

13. Information System Hosting, Operation, Maintenance, or Use

13.1 For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerablity scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor's security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA's network involving VA information must be reviewed and approved by VA prior to implementation.

13.2 Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA.

These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.

13.3 Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor's systems in accordance with VA Handbook 6500.3,

13.4 Certification and Accreditation and/or the VA OCS Certification Program Office.

Government- owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

13.5 The contractor/subcontractor's system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA's POA&M management process. The contractor/subcontractor must use VA's POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities.

Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/ subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re- authorized per VA Handbook

6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

13.6 The contractor/subcontractor must conduct an annual self assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

13.7 VA prohibits the installation and use of personally-owned or contractor/ subcontractor-owned equipment or software on VA's network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA-approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.

13.8 All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/ subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per

6500.1 requirements. This must be completed within 30 days of termination of the contract.

13.9 Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:

13.9.1 Vendor must accept the system without the drive;

13.9.2 VA's initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

13.9.3 VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

13.9.4 Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

13.9.4.1 The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and

13.9.4.2 Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation.

Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract.

13.9.4.3 A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.

14. Security Incident Investigation

14.1 The term "security incident" means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/ subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/ subcontractor has access.

14.2 To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

14.3 With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

14.4 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 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.

15. Liquidated Damages for Data Breach

15.1 Consistent with the requirements of 38 U.S.C. 5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

15.2 The contractor/subcontractor shall provide notice to VA of a "security incident" as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non- Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

15.3 Each risk analysis shall address all relevant information concerning the data breach, including the following:

15.3 1 Nature of the event (loss, theft, unauthorized access);

15.3.2 Description of the event, including:

15.3.2.1 date of occurrence;

15.3.2.2 data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

15.4 Number of individuals affected or potentially affected;

15.5 Names of individuals or groups affected or potentially affected;

15.6 Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

15.7 Amount of time the data has been out of VA control;

15.8 The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

15.9 Known misuses of data containing sensitive personal information, if any; (9) Assessment of the potential harm to the affected individuals;

15.10 Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

15.11 Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

15.12 Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

15.12.1 Notification;

15.12 2 One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

15.12.3 Data breach analysis;

15.12.4 Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

15.12.5 One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

15.12.6 Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

16. Security Controls Compliance Testing

16.1 On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-day's notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

17. TRAINING

17.1 All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

17.1 1 Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

17.1.2 Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

17.1.3 Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

17.1.4 Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document - e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

17.2 The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

17.3 Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, 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 training and documents are complete.

18. Option to Extend Services: In accordance with FAR Clause 52.217-8, Option to Extend Services, the contract may be extended, at the Government’s sole discretion, for a period of up to six (6) months, exercisable in increments of not less than one (1) month. If the contract contains an unexercised option period, the Government may elect to exercise the option pursuant to FAR Clause 52.217-9, Option to Extend the Term of the Contract, during any short-term extension. The short-term extension(s) shall be subtracted from the total duration of the immediately succeeding option period that may follow as a result of the exercise of the option pursuant to FAR Clause 52.217-9 so that the combination of the short-term extension(s) and the option will not exceed 12 months duration. If the Government exercises one or more short term extensions in accordance with FAR Clause 52.217-8 and this instruction or an option period pursuant to FAR Clause 52.217-9, or any combination thereof, the contract as extended shall be deemed to include this extension instruction and FAR Clause 52.217-8; thus, the authority to extend services pursuant to FAR Clause 52.217-8 and this instruction may be exercised at the end of the base period and at the end of each option period.

The prices applicable during the short-term extension(s) shall be the price(s) applicable during the immediately succeeding option period if there is one (for example, CLIN 1001 subject only to any adjustment required by the Service Contract Act). If there is no immediately succeeding option period, the price(s) shall be the price(s) applicable during the immediately preceding contract period, subject only to any adjustment required by the Service Contract Act.

The extension(s) may be exercised by the Government IAW FAR Clause 52.217-8, provided that the CO has given notice of the Government’s intent to exercise the extension at least 7 calendar days before this contract is to expire. A notice will be provided for each separate extension.

For requirements items, the prices applicable during the short-term extension(s) shall be the prices applicable during the immediately succeeding option period, if there is one. If there is no succeeding option period, the prices shall be the prices applicable during the immediately preceding contract period.

The cost ceiling(s), base fee(s), and award fee(s) during the short term option(s) shall be the pro rata portion of the costs and fees applicable to the immediately succeeding option period, if there is one. If there is no succeeding option period, the cost ceiling(s) and fee(s) shall be the pro rata portion of the costs and fees for the immediately preceding contract period.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SERVICES QTY UNIT UNIT PRICE AMOUNT

16,000.00 EA $0.45 $7,200.00

ClearRead Software as a Service: Licenses and Support ClearRead Xray, Bone Suppress, Detect

Contract Period: Base POP Begin: 12-10-2024 POP End: 12-09-2025

Funding/Req. Number: 1 $7,200.00 496-25-1-287-0011

10,001.00 EA $3.00 $30,003.00

ClearRead CT, Vessel Suppress, Detect, Compare

Contract Period: Base POP Begin: 12-10-2024 POP End: 12-09-2025

Funding/Req. Number: 1 $30,003.00 496-25-1-287-0011

16,400.00 EA $0.45 $7,380.00

Contract Period: Option 1 POP Begin: 12-10-2025 POP End: 12-09-2026

17,751.00 EA $3.60 $63,904.00

Contract Period: Option 1…