36C24E24R0003.docx

36C24E24R0003

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

240E 36C24E24R0003 06-03-2024 Michael Haydo 07-02-2024 10:00am

EDT

00240E Veterans Health Administration Regional Procurement Office East Building 32 Suite 1A1111 1010 Delafield Road Pittsburgh

PA

15215-1802 X X 541611 $24.5 Million N/A X US Department of Veterans Affairs Veteran Health Administration VA Boston Healthcare System 940 Belmont St Boston

MA

02301 00240E Veterans Health Administration Regional Procurement Office East Building 32 Suite 1A1111 1010 Delafield Road Pittsburgh

PA

15215-1802

00240E US Department of Veterans Affairs Financial Services Center (FSC) P.O. Box 149971 Austin

TX

78714-8971 X See CONTINUATION Page See schedule Five (5) year Indefinite Delivery/Requirements contract Estimated period of performance: 9/15/2024-9/14/2029 Services and individual performance periods will be awarded on individual task orders.

See CONTINUATION Page X X X Michael D. Haydo

PCOE14L3-67579

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C24E Michael Haydo Veterans Health Administration Regional Procurement Office East Building 32 Suite 1A1111 1010 Delafield Road Pittsburgh PA 15215-1802

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

3. INVOICES: Invoices shall be submitted in arrears:

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

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

36C24E24R0003

Page 1 of Page 1 of Statement of Work Million Veteran Program Printing and Mailing Support Services

1. Summary: This proposed Indefinite Delivery/Requirements contract will provide support to the VA’s Million Veteran Program (MVP), an initiative for the advancement of precision medicine. MVP is a part of the President’s Precision Medicine Initiative, a research effort to revolutionize how we improve health and treat disease, with an overarching goal of recruiting, engaging, and retaining at least one million Veterans for genomic and epidemiologic research. To support this goal, this contract will provide the necessary support and resources to facilitate primary data collection, as well as the program management, as needed, to drive Veteran recruitment, engagement, and retention. More specifically, to facilitate primary data collection for MVP, this contract will provide support to design and develop survey booklets, letters, and other printed materials, mail such materials, track responses and returned mailings. The returned surveys and paper correspondence from Veterans including self-reported PII/PHI, including highly protected information about mental health, substance use and lived experiences.

This proposed contract requires considerable ramp up actions by the vendor be able to handle an extraordinarily high volume of mailings (over 1 million mail pieces a year) along with unique mailing requirements for the 70+ VA Medical Centers. The contractor shall be ready at the start of the performance period to have all personnel and systems cleared for daily data exchanges of sensitive Veterans’ information between the vendor and the MVP associated with Health Insurance Portability and Accountability Act (HIPPA) and Privacy Act Veterans data. There is a robust VA process to maintain compliance with VA security system requirements in place, where the contractor shall have an Authority to Operate (ATO) in place at the beginning of the contractual period of performance to meet the information security required for successful performance of this contract.

2. TASKS AND ASSOCIATED DELIVERABLES

The Tasks and Associated Deliverables detailed below describe the anticipated services to be performed under this contract. However, specific taskings and deliverables will be issued under individual Task Orders.

Note: All letters and survey cover sheets should have VA logo (colored) and program logo (colored), survey instruction sheets should have program logo (colored), all questionnaire booklets and forms will be black/white with drop out color. Logo graphic will be provided electronically at contract award.

For tasks with design features, the contractor will design according to VA requirements, re-format as directed by the government and suggest design improvements to the government based on industry expertise. Design tasks will include integrating standard language into mailing materials that promote the MVP marketing/promotional messaging as provided by the government. The VA point of contact will be the Contracting Officer’s Representative (COR) Gino Jackson at gino.jackson@va.gov

Prior to any outbound mailing, the contractor will check the address against applicable USPS databases and remove any mailing that will not be delivered, change the address where a new address is provided and update the mailing database as directed by the government.

Task 1: PROJECT MANAGEMENT

The Contractor shall provide project management support across the MVP contract to include, but not be limited to, resource planning, controlling time management, cost estimating and developing the budget, ensuring proactive communication, analyzing and managing project risk, monitoring progress and providing estimate to complete projections twice each contract year.

Maintain all federal security and information requirements, such as, any relevant authority to operate (ATO), including regular scans and addressing all government requests related to data sharing and data connections.

A Project Management Plan (PMP) that lays out the contractor’s approach, timeline and tools shall be provided with the offeror’s proposal and then finalized for the contract period of performance and in the execution of each Peer Review cycle by Service. The PMP shall include a narrative and graphic format displaying schedule, specifically defined milestones, risks, communication, and resource support. The PMP shall explain how the contractor will coordinate and execute planned, routine, ad hoc requirements as identified in SOW. Upon acceptance, initial PMP will be considered baseline and shall be updated as needed. Any changes to the schedule/project plan shall be subject to COR written approval. The PMP shall include the following elements:

· Meetings/teleconferences

· Project documentation submissions/revisions

· Developmental efforts structured to reflect development of a deliverable product

· Project milestones

· Deliverables

· Communication Plan

· Quality Control Plan

· Status Reports Task 2: DESIGN, PRINT, MAIL/REMAIL BASELINE SURVEY PACKET The contractor shall print and mail the initial recruitment packet:

· 1-page (1-sided) recruitment letter with color and populated information

· Informational brochure duplex glossy paper 8.5”x 11”

· Pre-folded Baseline Survey to fit into 5.75”x 9” envelope comprised of 3 - 11” x 17” pages (duplex) with PT ID and color

· Preaddressed 5.75”x 9” BRE to contractor

· 6”x10” window envelope with black VA seal, program name and c/o contractor’s return address.

· The contractor shall track all received surveys and re-mail the initial recruitment packet (with revised recruitment letter) to non-respondents from the initial mailing with timeline to be determined by VA.

· If mail undeliverable and forwarding address provided, notify VA of new address. Do not resend packets.

Task 3: DESIGN, PRINT, MAIL/REMAIL POSTCARD PACKET (3rd and 4th mailing) The contractor shall print and mail an additional recruitment/informational packet, can be utilized for both main program and sub-program re-contact, to include:

· 1-page (1-sided) recruitment/informational letter with color (duplex)

· Preaddressed 4” x 6” postcard (duplex) with BRM to contractor with PT ID and color (postcard to

· Include check boxes to indicate interest in participation and opt-out options.)

· Mailed in a #10 window envelope with black VA seal, program name and c/o contractors return address.

Task 4: DESIGN, PRINT, MAIL APPOINTMENT PACKET

For Veterans who have a MVP scheduled program visit, the contractor shall print and mail:

· 1-page appointment letter with color and populated information

· 1- 8.5” x 11” pages (duplex) of a consent brochure

· Mailed in a #10 window envelope with black VA seal, program name and c/o contractors return address.

Task 5: DESIGN, PRINT, MAIL MODIFIED APPOINTMENT PACKET For Veterans who schedule a program visit but have not received an invitational mailing, the contractor shall print and mail:

· 1-page appointment letter with color and populated information

· Pre-folded Baseline Survey to fit into 5.75”x 9” envelope comprised of 3 - 11” x 17” pages (duplex) with PT ID and color

· Informational brochure

· 1- 8.5” x 11” pages (duplex) of a consent brochure

· Preaddressed 5.75”x 9” BRE to contractor

· 6”x10” window envelope with black VA seal, program name and c/o contractor’s return address.

Task 6: DESIGN, PRINT, MAIL BASELINE SURVEY REMINDER PACKET For Veterans who have not returned the Baseline Survey but have enrolled in MVP, the contractor shall print and mail:

· 1-page Baseline Survey reminder letter with color

· pre-folded Baseline Survey to fit into 5.75”x 9” envelope comprised of 3 - 11” x 17” pages (duplex) with PT ID and color (cover page of booklet includes check box to opt-out and information regarding best day/time for an appointment)

· Preaddressed 5.75”x 9” BRE to contractor

· 6”x10” window envelope with black VA seal, program name, and c/o contractor’s return address.

Task 7: DESIGN, PRINT, MAIL/RE-MAIL LIFESTYLE SURVEY PACKET

For Veterans who have enrolled in MVP, the contractor shall print and mail:

· 1-page thank you letter with color

· MVP Appreciation Pin for Veterans (either provided by this contractor or a separate contractor)

· A Lifestyle Survey booklet comprised of 5 - 11” x 17” pages (20-sided) with PT ID and color

· A preaddressed folded 9”x12” BRE returned to contractor,

· Mailed in a 9”x12” window envelope with black VA seal, program name and c/o contractor’s return address.

· For Veterans who do not return the Lifestyle Survey with timeline to be determined by VA , the contractor shall print and re-mail the thank you letter and lifestyle survey using a list defined by the VA.

· The contractor shall track all received surveys and re-mail the initial recruitment packet (with revised recruitment letter) to non-respondents from the initial mailing with timeline to be determined by VA.

· If mail undeliverable and forwarding address provided, notify VA of new address. Do not resend packets.

Task 8a: DESIGN, PRINT, MAIL WITHDRAWAL FORM REQUEST PACKET

For Veterans who have requested a withdrawal form, the contractor shall print and mail:

· 1-page letter with populated information

· 1-page withdrawal form with populated information

· Preaddressed #10 BRE to CERC

· 6”x10” window envelope with black VA seal, program name, and c/o contractor’s return address.

Task 8b: DESIGN, PRINT, MAIL WITHDRAWAL CONFIRMATION LETTER

For Veterans who have requested a withdrawal form, the contractor shall print and mail:

· 1-page letter with populated information

· Mailed in a #10 window envelope with black VA seal, program name and c/o contractors return address.

Task 9: DESIGN, PRINT, MAIL APPOINTMENT CHANGE/CANCELLATION LETTER

To notify Veterans of an appointment change or cancellation, the contractor shall print and mail:

· 1-page letter with populated information.

Task 10: DESIGN, PRINT, MAIL INFORMED CONSENT PACKET

· 1-page letter with color and populated information

· 5- 8.5” x 11” pages (duplex) of a consent/HIPAA document

· Preaddressed 5.75”x 9” BRE to Ipsos

· 6”x10” window envelope with black VA seal, program name, and c/o contractor’s return address Task 11: RECEIPT AND SCAN OF RETURNED MATERIALS

Upon receipt of returned forms, such as, but not limited to the Baseline Survey, Lifestyle Survey, Follow-up Survey, Sub-Program Survey, scheduling, post-card and opt out forms, the contractor shall scan the documents into files and provide the files and images of the scanned documents to VA on a daily basis in formats to be determined by VA, via a VA approved secure transport mechanism. The files will consist of scanning audit data and all data collected on the returned documents.

The contractor will alert MAVERIC of any perceived life-threatening notes immediately upon review. Scanned data will be kept as back up for up to 3 years’ worth of data. Data will be destroyed per VA regulations for destruction of VA data. Once MVP has confirmed receipt of satisfactory image files, contractor will destroy the original paper documents in alignment with VA regulation for secure destruction of PHI/PII.

All other notes or correspondence received apart from the above scannable documents will be retrieved and reviewed by the contractor. The contractor will send appropriate templated correspondence back to the sender on behalf of MAVERIC. Contractor will flag new situations for template development and work closely with MAVERIC to ensure contractor executes excellent customer service to all correspondence received on behalf of MAVERIC. The contractor will extract specific details from these communications for tracking and share that extracted data along with scanned versions of these documents to MAVERIC via a VA approved secure transport mechanism and per workable schedule to be determined by both MAVERIC and the contractor. This work will be subject to quality control review by MAVERIC. Results of that review will be shared with contractor and contractor and MAVERIC will adjust processes as needed to ensure excellent customer service is experienced by all who send correspondence.

The contractor will maintain the capability to scan documents that are printed at the recruitment sites and may have slight variabilities in print size, margins, etc.

Task 12: DESIGN, PRODUCTION AND DISTRIBUTION OF PUBLIC RELATIONS MATERIALS The contractor shall have the capability to design, produce and distribute various types and quantities of public relations materials as communicated by government project team.

Potential public relations materials could include, among other items, the following:

· Design material based on VA general outline/guidance.

· VA signs off on final product prior to production.

· Posters (standard, foam back, pull-up, free-standing, etc.)

· Information Brochure

· Consent Brochure

· Banners

· Tent cards

· Fact Sheets

· Location Cards

· Distribution could either be bulk shipment to MAVERIC or recruitment sites.

Task 13: DESIGN, PRODUCTION AND DISTRIBUTION OF PINS, PENS AND/OR COINS

The contractor shall have the capability to design, produce and distribute lapel pins, pens, and/or coins as communicated by government project team.

· Design material based on VA general outline/guidance.

· VA signs off on final product prior to production.

· Distribution to individual participants or bulk shipment.

Task 14a: DESIGN, PRODUCTION AND DISTRIBUTION OF MVP NEWSLETTER

The contractor shall have the capability to design, produce and distribute a MVP newsletter with information provided by the government project team.

· Design material based on VA general outline/guidance.

· VA signs off on final product prior to production.

· Distribution could either be bulk shipment to MAVERIC, CERC or recruitment sites or direct mail to individual program participants.

Task 14b: DESIGN, PRODUCTION AND DISTRIBUTION OF ANNUAL PERSONALIZED LETTERS (i.e. Veterans Day)

The contractor shall have the capability to design, produce and distribute annual personalized letters with information provided by the government project team.

· Design material based on VA general outline/guidance.

· VA signs off on final product prior to production.

· 5x7 color printed folded card on cardstock – personalized with corresponding sized envelope OR 1-page (duplex) letter with color in a #10 window envelope with black VA seal, program name and c/o contractors return address.

· Distribution is direct mail to individual program participants.

Task 15a: DESIGN, PRODUCTION AND DISTRIBUTION OF BUSINESS REPLY ENVELOPES

· The contractor shall produce and distribute 6”x10” Business Reply Envelopes (BRM) with black VA seal, program name, and c/o contractor’s return address.

· Distribution could either be bulk shipment to MAVERIC or recruitment sites.

Task 15b: DESIGN, PRODUCTION AND DISTRIBUTION OF THANK YOU PIN LETTERS

· 1-page (1-sided) letter with color

· Inclusion of an MVP Appreciation Pin (either provided by this contractor or a separate contractor)

· Mailed in a padded envelope, program name and c/o contractors return address.

· Distribution is direct mail to individual program participants.

Task 16: DESIGN, PRINT, MAIL/REMAIL OF SURVEY (Name and length of survey could change and will be priced each budget year.)

· Design (layout/format).

· 1-page (duplex) letter with color

· Pre-folded Baseline Survey to fit into 5.75”x 9” envelope comprised of 10 - 11” x 17” pages (duplex) with PT ID and color

· Preaddressed 5.75”x 9” BRE to contractor

· 6”x10” window envelope with black VA seal, program name and c/o contractor’s return address.

· The contractor shall track all received surveys and re-mail the initial recruitment packet (with revised recruitment letter) to non-respondents from the initial mailing with timeline to be determined by VA.

· If mail undeliverable and forwarding address provided, notify VA of new address. Do not resend packets.

Task 17: DESIGN, PRINT, MAIL/REMAIL OF SUB-PROGRAM SURVEY (Name and length of survey could change and will be priced each budget year.)

· Design (layout/format).

· 1-page (duplex) letter with color

· Pre-folded Baseline Survey to fit into 5.75”x 9” envelope comprised of 3 - 11” x 17” pages (duplex) with PT ID and color

· Preaddressed 5.75”x 9” BRE to contractor

· 6”x10” window envelope with black VA seal, program name and c/o contractor’s return address.

· The contractor shall track all received surveys and re-mail the initial recruitment packet (with revised recruitment letter) to non-respondents from the initial mailing with timeline to be determined by VA.

· If mail undeliverable and forwarding address provided, notify VA of new address. Do not resend packets.

Task 18: DESIGN, PRODUCTION AND DISTRIBUTION OF PERSONALIZED LETTERS (i.e. invitation to enroll online after completing baseline survey or to complete surveys online after enrollment at site). The contractor shall have the capability to design, produce and distribute annual personalized letters with information provided by the government project team.

· Design material based on VA general outline/guidance.

· The VA Contracting Officer’s Representative will sign off on final product prior to production.

· 1-page (1-sided) letter with color

· Mailed in a #10 window envelope with black VA seal, program name and c/o contractors return address.

· Distribution is direct mail to individual program participants.

MARCH 12, 2010

VA HANDBOOK 6500.6

APPENDIX B

VA ACQUISITION REGULATION SOLICITATION PROVISION AND CONTRACT CLAUSE

NOTE: This clause will undergo official rule making by the Office of Acquisitions and Logistics. The below language will be submitted for public review through the Federal Register. The final wording of the clause may be changed from what is outlined below based on public review and comment. Once approved, the final language in the clause can be obtained from the Office of Acquisitions and Logistics Programs and Policy.

1. SUBPART 839.2 – INFORMATION AND INFORMATION TECHNOLOGY SECURITY REQUIREMENTS

839.201 Contract clause for Information and Information Technology Security:

a. Due to the threat of data breach, compromise or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media).

b. In solicitations and contracts where VA Sensitive Information or Information Technology will be accessed or utilized, the CO shall insert the clause found at 852.273-75, Security Requirements for Unclassified Information Technology Resources.

2. 852.273-75 - SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES (INTERIM- OCTOBER 2008)

As prescribed in 839.201, insert the following clause:

The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

(END OF CLAUSE)

MARCH 12, 2010

VA HANDBOOK 6500.6

APPENDIX C

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR

INCLUSION INTO CONTRACTS, AS APPROPRIATE

1. GENERAL

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

840 ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

840.201 A contractor/subcontrator 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.

840.202 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.

840.203 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.

840.204 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.

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

3. VA INFORMATION CUSTODIAL LANGUAGE

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

- General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems 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.

c. 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.

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

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

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

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

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

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

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

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

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

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

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

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

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

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

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

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

g. The contractor/subcontractor agrees to:

(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:

(a) The Systems of Records (SOR); and

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

(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

(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.

h. 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.

(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.

(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 voiceprint, or a photograph.

(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.

i. 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.

j. 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.

k. 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 5 days.

l. 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.

5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

a. 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 vulnerability 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 COTR 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.

b. 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.

c. 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, 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.

d. 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, and Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

e. 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 COTR. 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.

f. 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.

g. 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.

h. 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:

(1) Vendor must accept the system without the drive;

(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

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

(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;

(a) 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

(b) 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.

(c) 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.

6. SECURITY INCIDENT INVESTIGATION

a. 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 COTR 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.

b. 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.

c. 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.