P02 RFI DRAFT PD for HealthLevel Foundations Radiology Analytics platform.docx

VISN 8 Radiology Analytics System

PRODUCT DESCRIPTION

DEPARTMENT OF VETERANS AFFAIRS

Veterans Health Administration VISN 8 Radiology Analytics System

Date: May 27, 2025

PWS Version Number: 1.0

BackGround The Department of Veterans Affairs, VA Sunshine Healthcare Network, Veterans Integrated Service Network 8 (VISN 8), employs approximately 144 full time Radiologists across 7 facilities and utilizes the Philips IntelliSpace Picture Archive and Communication System (PACS) for managing the electronic images and workflow to ensure all imaging exams are read, and have reports completed for them. For the last five years VISN 8 has employed the HealthLevel Foundations Radiology Analytics platform to gather data from VistA from all VISN 8 Facilities, including imaging order data, scheduled appointments, lab results, imaging reports, etc. and combined this data in the Foundations database to perform extensive analytics and customized real-time reports for Radiology leadership. Foundations has been expanded Order Management, Workload and Appointment Analysis, Case Data Analytics, Radiology Order Protocoling, Ongoing Professional Practice Evaluation (OPPE)/Peer Review, and Patient Flow modules.

REQUIREMENTS

VISN 8 requires a follow-on contract for the continued licensing and support of the Foundations Radiology Analytics system capable of supporting 1.5 million cases annually and shall have a study volume license up to a minimum of 1.2 million annual cases. Volume must be based on DICOM Study Instance Unique Identifier (SIUID) reported from the VISN 8 PACS system.

Contractor must have remote Virtual Private Network (VPN) access to the existing systems to provide ongoing support, maintenance, management and upgrades for the system. Contractor shall comply with applicable VA security clauses and provide remote support and maintenance for the selected system via VA virtual private network (VPN).

Contractor is required to provide E-mail and telephone support during the hours of 8 am to 6 pm Pacific Time. Emergency 24x7 pager response is also required; response time shall be within 2 hours following the receipt of the emergency call. Contract shall schedule support to include maintenance bug fixes, feature updates and upgrades to existing modules with 99.9% uptime. Base system must provide a fully integrated interface to other existing modules. Contractor shall provide ongoing interface and data extracts from the VISN 8 Picture Archive Communication System (PACS) system and VistA systems to include HL7 messages for ORM order messages and HL7 Lab results for use in Exam Protocolling.

The following components/modules are to be included in the agreement.

Period of Performance

The period of performance is 12-months, with four (4) option periods. The first period of performance will begin at award and will end one year after award. Subsequent option years will begin on the day after the end of the current period of performance.

Support and Maintenance

Support Maintenance for the above includes the following:

1. Maintenance, bug fixes and feature updates

2. Upgrades to deployed functions/modules

3. Email and 8AM to 6PM Pacific Time phone support

4. Scheduled web-based Administrator training

5. Emergency 24x7 pager notification for support

Option for additional increments Option for additional increments above 1.2 million studies per year includes:

1. System capability to expand designated studies per year up to 1.5 million studies per year

2. Increments may be added as options in 50,000 study tiers or other metrics as specified and negotiated with vendor

3. Study volume addition may be achieved in base year or option years.

Invoicing

1. Invoicing for items 1 through 4 may be invoiced as “subscriptions” at the beginning of the period of performance.

2. Invoicing for items 5, 6, and 7 may only be invoiced in arrears for the Facilities utilizing those modules and should correspond to the volume of exams conducted within those modules.

GRAY MARKET GOODS

(Refer to the notes to the Contracting Officer section for instructions related to response requirements)

The Contractor must provide only new equipment and new parts for the required products described herein; no used, refurbished, or remanufactured equipment or parts shall be provided under any circumstances. Absolutely no “Gray Market Goods” or “Counterfeit Electronic Parts” shall be provided. Gray Market Goods are defined as genuine branded goods intentionally or unintentionally sold outside of an authorized sales-territory or by non-authorized dealers in an authorized territory. All equipment shall be accompanied by the Original Equipment Manufacturers (OEM’s) warranty. Counterfeit Electronic Parts are defined as unlawful or unauthorized reproduction, substitution, or alteration that has been knowingly mismarked, misidentified, or otherwise misrepresented to be an authentic, unmodified electronic part from the original manufacturer, or a source with the express written authority of the original manufacturer or current design activity, including an authorized aftermarket manufacturer. Unlawful or unauthorized substitution includes used electronic parts represented as new, or the false identification of grade, serial number, lot number, date code, or performance characteristics.

NOTICE OF THE FEDERAL ACCESSIBILITY LAW AFFECTING ALL INFORMATION AND COMMUNICATION TECHNOLOGY (ICT) PROCUREMENTS (SECTION 508)

(Three standards listed in Section 2.1 below [E205 Electronic Content – (Accessibility Standard -WCAG 2.0 Level A and AA Guidelines), E204 Functional Performance Criteria, and E208 Support Documentation and Services] always apply to the evaluation of ICT and should remain marked as “x”. The requiring activity should un-mark any of the other remaining standards below [E206 and/or E207] that do not apply to this effort. The Accessibility Requirements Tool (ART) is a web-based application that will help the requiring activity determine the Section 508 standards that apply to their specific acquisition. The ART tool is located at https://app.buyaccessible.gov/home.)

On January 18, 2017, the Architectural and Transportation Barriers Compliance Board (Access Board) revised and updated, in a single rulemaking, standards for electronic and information technology developed, procured, maintained, or used by Federal agencies covered by Section 508 of the Rehabilitation Act of 1973, as well as our guidelines for telecommunications equipment and customer premises equipment covered by Section 255 of the Communications Act of 1934. The revisions and updates to the Section 508-based standards and Section 255-based guidelines are intended to ensure that information and communication technology (ICT) covered by the respective statutes is accessible to and usable by individuals with disabilities.

SECTION 508 – INFORMATION AND COMMUNICATION TECHNOLOGY (ICT) STANDARDS

The Section 508 standards established by the Access Board are incorporated into, and made part of all VA orders, solicitations and purchase orders developed to procure ICT. These standards are found in their entirety at: https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines. A printed copy of the standards will be supplied upon request.

Federal agencies must comply with the updated Section 508 Standards beginning on January 18, 2018. The Final Rule as published in the Federal Register is available from the Access Board: https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule.

The Contractor shall comply with “508 Chapter 2: Scoping Requirements” for all electronic ICT and content delivered under this contract. Specifically, as appropriate for the technology and its functionality, the Contractor shall comply with the technical standards marked here:

COMPATABILITY WITH ASSISTIVE TECHNOLOGY

The standards do not require installation of specific accessibility-related software or attachment of an assistive technology device. Section 508 requires that ICT be compatible with such software and devices so that ICT can be accessible to and usable by individuals using assistive technology, including but not limited to screen readers, screen magnifiers, and speech recognition software.

ACCEPTANCE AND ACCEPTANCE TESTING

Deliverables resulting from this solicitation will be accepted based in part on satisfaction of the Section 508 Chapter 2: Scoping Requirements standards identified above.

The Government reserves the right to test for Section 508 Compliance before delivery. The Contractor shall be able to demonstrate Section 508 Compliance upon Deliverables resulting from this solicitation will be accepted based in part on satisfaction of the Section 508 Chapter 2: Scoping Requirements standards identified above.

The Government reserves the right to test for Section 508 Compliance before delivery. The Contractor shall be able to demonstrate Section 508 Compliance upon delivery.

SHIPMENT OF HARDWARE OR EQUIPMENT

Inspection: Destination Acceptance: Destination Free on Board (FOB): Destination

Ship to and Mark For:

Name:

Address:

Voice:

Email:

SPECIAL SHIPPING INSTRUCTIONS

Prior to shipping, Contractor shall notify Site POCs, by phone followed by email, of all incoming deliveries including line-by-line details for review of requirements. The Contractor shall not make any changes to the delivery schedule at the request of Site POC.

Contractors shall coordinate deliveries with Site POCs before shipment of TBD to ensure sites have adequate storage space.

All shipments, either single or multiple container deliveries, shall bear the VA IFCAP Purchase Order number on external shipping labels and associated manifests or packing lists. In the case of multiple container deliveries, a statement readable near the VA IFCAP PO number shall indicate total number of containers for the complete shipment (e.g. “Package 1 of 2”), clearly readable on manifests and external shipping labels.

Packing Slips/Labels and Lists shall also include the following:

The IFCAP PO number is located in block #20 of the SF 1449

Project Description: Foundations Radiology Analytics System

Total number of Containers: Package ___ of ___. (e.g., Package 1 of 3)

Shipment/Delivery Kick-off Meeting

Contractor shall not commence performance on the tasks in this Product Description until after the kickoff meeting or has been advised by the Contracting Officer that a kickoff meeting is waived.

The Contractor shall conduct a Shipment/Delivery Kick-off Meeting with the VA Program Manager (PM), COR, Delivery Date Coordinator, Implementation Manager, and Facility CIOs (or designee) to discuss delivery schedule requirements and facilitate delivery of equipment. This meeting may be held in conjunction with the post award conference or identified technical kickoff meeting, if applicable. The Contractor shall also present the Shipment/Delivery Weekly Progress Report format for review and approval by the Government. This meeting, if held independently, shall be conducted telephonically within ten days after award and shall incorporate any delivery schedule changes to the draft Delivery Schedule identified by the Government.

Shipment/Delivery Weekly Progress Report

The Contractor shall provide a Shipment/Delivery Weekly Progress Report which shall identify the items shipped, the serial number associated with each piece of equipment; the date of each shipment; the status of each shipment, tracking information, and information relative to Government-receipt of the equipment items at each delivery site. In addition, the Shipment/Delivery Weekly Progress Report shall identify any problems and provide a description of how the problems were resolved/addressed. If problems have not been completely resolved, the Contractor shall provide an explanation and status of resolution. Shipment/Delivery Weekly Progress Reports shall be submitted in Microsoft Excel Format and shall clearly identify each serial number of the equipment being delivered with one (1) serial number per cell.

Inspection: Destination Acceptance: Destination Free on Board (FOB): Destination

Packing Slips/Labels and Lists shall also include the following:

IFCAP PO #: ____________ (e.g., 166-E11234 (the IFCAP PO number is located in block #20 of the SF 1449)) Project Description: (e.g. Tier 1 Lifecycle Refresh)

Total number of Containers: Package ___ of ___. (e.g., Package 1 of 3)

Deliverables:

A. Master Delivery Schedule B. Shipment/Delivery Weekly Progress Report

GENERAL REQUIREMENTS

The contractor shall comply with this Product Description and all work will be coordinated with the Contracting Officer Representative (COR). Prior to payment issuance, the COR will be required to validate satisfactory completion of each line item.

SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES

The contractor shall maintain current security configuration for all servers provided as part of the Foundations Radiology Analytics system, as well as system updates to ensure compatibility/functionality with current Microsoft Windows operating systems.

Changes to Product Description Any changes to this Product Description shall be authorized and approved only through written correspondence from the Contracting Officer (CO). A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

Reporting Requirements The contractor shall provide the Contracting Officer’s Representative (COR) with monthly written progress reports. Reports may be provided by hard copy or electronic mail. These are due to the COR by end of each month throughout the project's duration.

The progress report will cover all work completed during the preceding month and will present the work to be accomplished during the subsequent month. This report will also identify any problems that arose and a statement explaining how the problem was resolved. This report will also identify any problems that have arisen but have not been completely resolved with an explanation.

Travel Travel is generally only required for the initial classroom training for each site during the implementation period. Remote support is the normal method for assistance and installation of upgrades

Government Responsibilities The VA provides access to the VA network through Citrix Access Gateway (CAG) or Azure Virtual Desktop (AVD) for contractor staff who have completed security and education requirements to access the VA network. Access to the Radiology Data Analytics system will be provided to contractor staff via the CAG/AVD. The Government will maintain the CAG/AVD and any necessary Access Control List entries to ensure access to those servers as long as training and security requirements are maintained.

Contractor experience requirement – key personnel Skilled experienced professional and/or technical personnel are essential for successful contractor accomplishment of the work to be performed under this contract and subsequent task orders and option. These are defined as key personnel and are those persons whose resumes were submitted. The contractor agrees that the key personnel shall not be removed, diverted, or replaced from work without approval of the CO and COR.

Any personnel the contractor offers as substitutes shall have the ability and qualifications equal to or better than the key personnel being replaced. Requests to substitute personnel shall be approved by the COR and the CO. All requests for approval of substitutions in personnel shall be submitted to the COR and the CO within 30 calendar days prior to making any change in key personnel. The request shall be written and provide a detailed explanation of the circumstances necessitating the proposed substitution. The contractor shall submit a complete resume for the proposed substitute, any changes to the rate specified in the order (as applicable) and any other information requested by the CO needed to approve or disapprove the proposed substitution. The CO will evaluate such requests and promptly notify the contractor of approval or disapproval thereof in writing.

Security - Information System Security

The contractor shall ensure adequate LAN/Internet, data, information, and system security in accordance with VA standard operating procedures and standard contract language, conditions laws, and regulations. All government data shall be protected behind an approved firewall. Any security violations or attempted violations shall be reported to the VA project manager and Information Security Officer as soon as possible. The contractor shall follow all applicable VA policies and procedures governing information security, especially those that pertain to certification accreditation.

In accordance with the Veterans Affair Acquisition Regulation (VAAR) security clause, 852.273-75 “Security Requirements for Unclassified Information Technology Resources,” the contractor and their personnel shall be subject to the same Federal laws, regulations, standards and VA policies as VA personnel, regarding information and information system security. These include but are not limited to Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the Department of Commerce's National Institute of Standards and Technology (NIST). This also includes the use of common security configurations available from NIST's Web site at: http://checklists.nist.gov. To ensure that appropriate security controls are in place, Contractors must follow the procedures set forth in "VA Information and Information System Security/Privacy Requirements for IT Contracts" located at the following Web site: VA Handbook 6500.6.”

Security Training All contractor employees and subcontractors under this contract or order are required to complete the VA's on-line Security Awareness Training Course and the Privacy Awareness Training Course annually. Contractors must provide signed certifications of completion to the CO during each year of the contract. This requirement is in addition to any other training that may be required of the contractor and subcontractor(s).

Contractor Personnel Security

All contractor employees who require access to the Department of Veterans Affairs' computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Security and Investigations Center (07C). The level of background security investigation will be in accordance with VA Directive 0710 dated September 10, 2004 and is available at: VA Handbook 0710, Appendix A, Tables 1 - 3). Appropriate Background Investigation (BI) forms will be provided upon contract (or task order) award and are to be completed and returned to the VA Security and Investigations Center (07C) within 30 days for processing. Contractors will be notified by 07C when the BI has been completed and adjudicated. These requirements are applicable to all subcontractor personnel requiring the same access. If the security clearance investigation is not completed prior to the start date of the contract, the employee may work on the contract while the security clearance is being processed, but the contractor will be responsible for the actions of those individuals they provide to perform work for the VA. In the event that damage arises from work performed by contractor personnel, under the auspices of the contract, the contractor will be responsible for resources necessary to remedy the incident.

The investigative history for contractor personnel working under this contract must be maintained in the databases of either the Office of Personnel Management (OPM) or the Defense Industrial Security Clearance Organization (DISCO). Should the contractor use a vendor other than OPM or Defense Security Service (DSS) to conduct investigations, the investigative company must be certified by OPM/DSS to conduct contractor investigations.

1. Background Investigation

The position sensitivity impact for this effort has been designated as [LIMITED] Risk and the level of background investigation is [NACI].

2. Contractor Responsibilities

a. The contractor shall bear the expense of obtaining background investigations. If the investigation is conducted by the Office of Personnel Management (OPM) through the VA, the contractor shall reimburse the VA within 30 days.

b. Background investigations from investigating agencies other than OPM are permitted if the agencies possess an OPM and Defense Security Service certification. The Vendor Cage Code number must be provided to the Security and Investigations Center (07C), which will verify the information and advise the contracting officer whether access to the computer systems can be authorized.

c. The contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain a U.S. citizenship and are able to read, write, speak and understand the English language.

d. After contract award and prior to contract performance, the contractor shall provide the following information, using Attachment B, to the CO:

(1) List of names of contractor personnel.

(2) Social Security Number of contractor personnel.

(3) Home address of contractor personnel or the contractor's address.

e. The contractor, when notified of an unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract.

1. Failure to comply with the contractor personnel security requirements may result in termination of the contract for default.

g. Further, the contractor will be responsible for the actions of all individuals provided to work for the VA under this contract. In the event that damages arise from work performed by contractor provided personnel, under the auspices of this contract, the contractor will be responsible for all resources necessary to remedy the incident.”

3. Government Responsibilities 1.

a. The VA Security and Investigations Center (07C) will provide the necessary forms to the contractor or to the contractor's employees after receiving a list of names and addresses.

b. Upon receipt, the VA Security and Investigations Center (07C) will review the completed forms for accuracy and forward the forms to OPM to conduct the background investigation.

c. The VA facility will pay for investigations conducted by the OPM in advance. In these instances, the contractor will reimburse the VA facility within 30 days.

d. The VA Security and Investigations Center (07C) will notify the contracting officer and contractor after adjudicating the results of the background investigations received from OPM.

e. The contracting officer will ensure that the contractor provides evidence that investigations have been completed or are in the process of being requested.

VA TECHNICAL REFERENCE MODEL

The Contractor shall support the VA enterprise management framework. In association with the framework, the Contractor shall comply with OI&T Technical Reference Model (VA TRM). The VA TRM is one component within the overall Enterprise Architecture (EA) that establishes a common vocabulary and structure for describing the information technology used to develop, operate, and maintain enterprise applications. Moreover, the VA TRM, which includes the Standards Profile and Product List, serves as a technology roadmap and tool for supporting OI&T. Architecture & Engineering Services (AES) has overall responsibility for the VA TRM.

POINTS OF CONTACTS

VA Program Manager / Contracting Officer’s Representative :

Contracting Officer:

Name:

Address:

Voice:

Email:

Contract Specialist:

Name:

Address:

Voice:

Email:

ADDITIONAL ITEMS

SPECIAL INSTRUCTIONS/REMARKS

<To ensure that the Offeror is an authorized reseller and will not provide gray market or counterfeit products or parts, the following shall be included in the Solicitation’s Response Instructions>

Response Instructions: Offerors shall provide with its quote/proposal a letter from the OEM for any and all proposed products certifying that the Offeror or the Offeror’s teaming partner, if acquiring the product through a teaming partner, is authorized to sell and provide the proposed product(s) as of the date of the submission of the quote/proposal. The OEM letter shall be provided on the OEM’s letterhead and signed by an authorized representative of the OEM. Additionally, the Offeror’s quote/proposal shall explicitly self-certify that that it will not provide Gray Market Goods and/or Counterfeit Electronic Parts, and that it has the level of certification/specialization, as required by the OEM(s), to support authorized product sale and pricing for the products proposed. Failure to include the requisite OEM letter(s) and Offeror self-certification may render the Offeror’s quote Unacceptable and thus, ineligible for award.

INFORMATION SECURITY CONSIDERATIONS:

(Refer to Question #6 from the Security Checklist, Appendix A in the 6500.6 Handbook. If the answer is “No”, include the below language.)

The Assessment and Authorization (A&A) requirements do not apply and a Security Accreditation Package is not required

(If the acquisition contains a maintenance type service, include the below language.)

All VA sensitive information shall be protected at all times in accordance with local security field office System Security Plans (SSP’s) and Authority to Operate (ATO)’s for all systems/LAN’s accessed while performing the tasks detailed in this Product Description.

(AT A MINIMUM, maintenance/installation (warranty) contracts, in which VA sensitive information and/or systems are accessed by a VA contractor/subcontractor require the following five requirements per 38 U.S.C. §§ 5723 and 5725.)

a. A prohibition on unauthorized disclosure: “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. A requirement for data breach notification: Upon discovery 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, the Contractor/Subcontractor shall immediately notify the COR and simultaneously, the designated ISO, and Privacy Officer for the contract. 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. See VA Handbook 6500.6, Appendix C, paragraph 6.a.

c. A requirement to pay liquidated damages in the event of a data breach: “In the event of a data breach or privacy incident involving SPI the contractor processes or maintains under this contract, the contractor shall be liable to VA for liquidated damages for a specified amount per affected individual to cover the cost of providing credit protection services to those individuals.” However, it is the policy of VA to forgo collection of liquidated damages in the event the Contractor provides payment of actual damages in an amount determined to be adequate by the agency.

Based on the determinations of the independent risk analysis, the Contractor shall be responsible for paying to 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:

1) Notification;

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

3) Data breach analysis;

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

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

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

d. A requirement for annual security/privacy awareness training: “Before being granted access to VA information or information systems, all Contractor employees and Subcontractor employees requiring such access shall complete on an annual basis either: (i) the VA security/privacy awareness training (contains VA security/privacy requirements) within 1 week of the initiation of the contract, or (ii) security awareness training provided or arranged by the contractor that conforms to VA’s security/privacy requirements as delineated in the hard copy of the VA security awareness training provided to the Contractor. If the Contractor provides their own training that conforms to VA’s requirements, they will provide the COR or CO, a yearly report (due annually on the date of the contract initiation) stating that all applicable employees involved in VA’s contract have received their annual security/privacy training that meets VA’s requirements and the total number of employees trained. See VA Handbook 6500.6, Appendix C, paragraph 9.

e. A requirement to sign VA’s Rules of Behavior: “Before being granted access to VA information or information systems, all Contractor employees and Subcontractor employees requiring such access shall sign on annual basis an acknowledgement that they have read, understand, and agree to abide by VA’s Contractor Rules of Behavior which is attached to this contract.” See VA Handbook 6500.6, Appendix C, paragraph 9, and Appendix D. Note: If a medical device vendor anticipates that the services under the contract will be performed by 10 or more individuals, the Contractor Rules of Behavior may be signed by the vendor’s designated representative. The contract must reflect by signing the Rules of Behavior on behalf of the vendor that the designated representative agrees to ensure that all such individuals review and understand the Contractor Rules of Behavior when accessing VA’s information and information systems.

(For procurements which include continuous/full-time/on-site technical support being acquired with the hardware/software, additional information security requirements may apply. Refer to the Security Checklist, Appendix A in the 6500.6 Handbook, especially responses to questions 3, 4, and 5, for instructions concerning any additional security requirements.

If it is determined that additional security requirements apply, delete the five (5) paragraphs in this section above and replace them with Addendum B below.

For PD’s that do not require these additional security requirements, Addendum B may be deleted.)

ADDENDUM B – VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE

(Addendum B must be tailored according to the requirements of the effort. Use the “Crosswalk” section of the “Flowchart and Guide, 6500.6 Appendix A” for assistance in determining the required sections to be included in the PD. Instructions in blue text before each section is general guidance, for more specific guidance, please refer to the “Flowchart and Guide, 6500.6. Appendix A”)

(Also, in Section B4, please complete the fill-in-the blank areas based upon the specific requirement for the current effort.)

APPLICABLE PARAGRAPHS TAILORED FROM: THE VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE, VA HANDBOOK 6500.6, APPENDIX C, MARCH 12, 2010

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 and VA personnel regarding information and information system security.

ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

(Include this section if any of the answers to Questions 4 or 5 or 6 or 7 from the Information Security Checklist are a yes)

a. 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 (e.g. Business Associate Agreement, Section 3G), 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 CO 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 CO must also be notified immediately by the Contractor or Subcontractor prior to an unfriendly termination.

VA INFORMATION CUSTODIAL LANGUAGE

(Include this section if any of the answers to Questions 4 or 5 or 6 or 7 from the Information Security Checklist are a yes)

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 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).

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 information is returned to 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.

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 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 CO within 30 days of termination of the contract.

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 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.

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.

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.

7. If a VHA contract is terminated for cause, the associated Business Associate Agreement (BAA) must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.05, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

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.

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

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 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 CO for response.

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 CO for response.

12. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require Assessment and Authorization (A&A) or a Memorandum of Understanding-Interconnection Security Agreement (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.

INFORMATION SYSTEM DESIGN AND DEVELOPMENT

(Include this section if any of the answers to Questions 5 or 6 or 7 from the Information Security Checklist are a yes. Delete the text within this section if the answer to Question 4 is a yes and the remaining Questions are a NO. If it is determined that this section is N/A, then indicate as such under the Section Title, do not delete the section (This will keep the numbering of the sections consistent.))

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 VA Handbook 6500, Risk Management Framework for VA Information Systems – Tier 3: VA Information Security Program, and the TIC Reference Architecture). 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 6508, Implementation of Privacy Threshold Analysis and Privacy Impact Assessment.

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 VA. This includes Internet Explorer 11 configured to operate on Windows 7 and future versions, as required.

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.

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

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, Risk Management Framework for VA Information Systems – Tier 3: VA Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.

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.

7. 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;

b. 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

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

8. 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.

c. “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.

9. 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, 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 vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

10. 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 _____days.

(Complete the fill-in above based upon the specific requirement (number of days) for the current effort, if known. If the specifics are unknown, replace the blue fill-in text above, in its entirety, with the following language, “based upon the severity of the incident.”)

11. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to 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 _____ days.

(Complete…