36C24E18Q0069-002.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. DUNS: DUNS+4:

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. 2/2012)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 60

36C24E18Q0069 03-13-2018

Michael Haydo 4128223158 03-19-2018

10:00 AM

00240E US Department of Veterans Affairs Veterans Health Administration Service Area Office (SAO) East 323 North Shore Drive, Suite 500 Pittsburgh PA 15212-5319

X 100

X

518210

$32.5 Million

N/A

US Department of Veterans Affairs VA Portland healthcare System

3710 SW US Veterans Hospital Rd Portland OR 97239

00240E

US Department of Veterans Affairs Veterans Health Administration Service Area Office (SAO) East 323 North Shore Drive, Suite 500 Pittsburgh PA 15212-5319

00240E

See electronic invoicing instructions

See CONTINUATION Page

See schedule

See CONTINUATION Page

X X

X 1

Michael D. Haydo

36C24E18Q0069

Table of Contents

SECTION A

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

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND COMPLIANCE (JUN

2011)

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

B.4 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (JAN

2017)

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

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

C.4 VAAR 852.203-70 COMMERCIAL ADVERTISING (JAN 2008)

C.5 VAAR 852.219-10 VA NOTICE OF TOTAL SERVICE-DISABLED VETERAN-OWNED

SMALL BUSINESS SET-ASIDE (JUL 2016)(DEVIATION)

C.6 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2012)

C.7 VAAR 852.237-70 CONTRACTOR RESPONSIBILITIES (APR 1984)

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

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2018)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JAN 2017)

E.2 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.3 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

ITEMS (NOV 2017)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

(continuation from Standard Form 1449, block 18A.)

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C24E Michael Haydo

US Department of Veterans Affairs

Veterans Health Administration

Service Area Office (SAO) East

323 North Shore Drive, Suite 500

Pittsburgh PA 15212-5319

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

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

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Upon receipt and acceptance by the VA.

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.

See electronic invoicing instructions

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

AMENDMENT NO DATE

B.2 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND

COMPLIANCE (JUN 2011)

This solicitation includes VAAR 852.219-10 VA Notice of Total Service- Disabled Veteran-Owned Small Business Set-Aside. Accordingly, any contract resulting from this solicitation will include this clause. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) retained by VA to assist in assessing the contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause.

To that end, the support contractor(s) may require access to contractor's offices where the contractor's business records or other proprietary data are retained and to review such business records regarding the contractor's compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor's compliance with the limitations on subcontracting or percentage of work performance requirement.

STATEMENT OF WORK

IRB WEB BASED RESEARCH PROTOCOL MANAGEMENT SYSTEM

A. GENERAL GUIDANCE

1. Title of Project: VA Portland Health Care System (VAPORHCS) Research Service Protocol and Committee Management System.

2. Background: VAPORHCS Research and Development (R&D) Service provides administrative support and oversight for all VA engaged research conducted within VAPORHCS or by VAPORHCS investigators while on official VA duty. Currently VAPORHCS oversees research which may be conducted at various locations to include, Oregon Health & Science University (OHSU), Vancouver Campus, VAPORHCS, Veteran Service Organizations (VSOs) and our Community Based Outpatient Clinics

(CBOCs). There are currently eight separate committees charged with the review of research protocols and oversight of research compliance. The Research & Development Committee (R&DC) has ultimate responsibility for approving all VAPORHCS research and has oversight of each of the following subcommittees: in-house Institutional Review Board (IRB), affiliate IRB, Subcommittee for Research Safety (SRS), Institutional Animal Care and Use Committee (IACUC), Central IRB (CIRB), National Cancer Institute (NCI) CIRB and affiliate Institutional Biosafety Committee (IBC). Both the affiliate IRB and affiliate IBC are run by OHSU, academic affiliate, however all approvals must be tracked and reported to the R&DC. Research investigators and staff are comprised of many dually appointed employees who maintain appointments with both VAPORHCS and OHSU. Many research projects are conducted at multiple sites, necessitating the need for protocol approval from both VA and the Affiliate. The CIRB is run by VA Central Office, Office of Research and Development, and oversees multi-site studies conducted at the VA; and NCI CIRB is run by the National Cancer Institute that oversees the review of Southwest Oncology Group cancer studies.

3. Scope of Work: The vendor shall provide a software subscription service, in the form of a web-based protocol management system that provides for online submission and tracking of VA research protocols through their lifecycle and archival. Contractor will provide and manage the infrastructure that houses research protocol information/data.

System will provide for at least five separate research committees/boards with the tools necessary to support the management, submission, review and oversight of all research protocols submitted to the VAPORHCS R&D (referred to as Customer).

At no time will Contractor have access to employee or patient Personally Identifiable Information (PII) or Protected Health Information (PHI). Employee emails and contact information will be stored in the system. VA shall own the rights to all data placed on the Contract Server. No software is to be placed on VA networks.

4. Performance Period: Base period of twelve months and four option periods of twelve months each.

5. Type of Contract: Firm-fixed-price for all periods.

B. SPECIFIC REQUIREMENTS

1. The Contractor shall provide a web-based research protocol management system that will provide electronic document management and web-based protocol sharing of electronic proposal submissions and reviews. The submission process shall include the ability to electronically sign documents which will be in compliance with CFR Title 21.

Contractors shall have experience with providing this service to other VA facilities.

System shall allow for utilization of electronic versions of Customer’s current forms and workflows and will provide the following:

a. Unlimited usage and accessibility via World Wide Web.

b. Hosting web interface: 24-hr security, long-term storage, automated backups, multiple fiber carriers, more than one power grid, FIPS 140.2 compliant and 508 compliant.

i. Frequency of backups should be at a minimum of once every 24 hours

c. Access for an unlimited number of users.

i. User accounts shall be password protected.

ii. Facilitates self-registration with approval by VA.

d. Access to protocol information to be limited to study personnel, research administrative staff, committee reviewers/members, Privacy Officer, Information Security Officer and Research Compliance Officer with access control regulated by VA, and internal and external auditors (e.g., Food and Drug Administration; Office of Research Oversight;

etc.).

e. Full review of research protocols required by the following review boards:

i. Research & Development Committee (R&DC)

ii. Institutional Review Board (IRB)

iii. Sub Committee for Research Safety (SRS)

iv. Institutional Animal Care & Use Committee (IACUC)

f. Tracking of VAPORHCS research protocols submitted to and approved by other Subcommittees shall allow for upload of protocol, approval letters, and other relevant correspondence for the following:

i. Affiliate IRB

ii. Institutional Biosafety Committee (IBC)

iii. Central Institutional Review Board (CIRB)

iv. National Cancer Institute CIRB

g. Unlimited smart form wizards and Customer defined fields for committees that are designed and implemented internally by VAPORHCS Research Administration Service.

Wizards shall include VA defined fields with questions that are dynamic in nature and shall direct the user to subsequent questions or additional forms based on the information provided. Questions shall not be repeated throughout any of the wizards.

Information compiled from the combination of wizards shall be organized and documented in a clear and concise manner that enables reviewers and committee members to easily interpret the information provided. Reports based on these form wizards shall be accessible by Research Service Administration Staff and have the capability to be queried by or restricted to specific date intervals, investigators, project types, performance locations, or other relevant attributes as determined by said staff, and should be exportable to other software such as MS Excel for further manipulation.

i. Proposed Project Questionnaire Wizard

1. Shall assign Protocol number for all new research proposals, this number will be utilized by all committees for the life of the protocol.

2. Shall include basic protocol information to include, principal investigator name, study title, study coordinator name, type of research being conducted, funding source, funding administrator, funding period, utilization of hospital resources, study staff, conflict of interest, exemption requirements, repository information (when applicable), clarification of research activities, and performance sites. Wizard shall be able to identify any and all subcommittees for which approval is required and direct the user on how to access appropriate wizard or upload other committee approvals. Questions shall be such that the wizard easily directs user to additional forms and/or wizards which will be required as part of the research submission process.

ii. Application for Initial and Continuing Review Questionnaires and Modifications Under IRB Review Wizard.

1. Shall not repeat any questions already asked as part of any previously used Wizard. Shall request information to include, but not limited to, screening and enrollment numbers, subject population, risk assessment, informed consent, research procedures, investigational drugs and/or devices, waivers of informed consent and/or HIPAA authorization, data storage, recruitment methods, and conflict of interest. Questions shall gather basic information about the research staff and their responsibilities so as to determine the additional training and/or credentialing that may be required.

Questions shall be such that the wizard easily directs user to additional forms and/or wizards which will be required as part of the research submission process.

iii. Application for Laboratory Science Initial and Continuing Review Study Wizard

1. Shall not repeat any questions already asked as part of any previously used Wizard. Shall request information regarding the use of wet lab space, human cell or tissue samples, shipping of biological hazards, microbial agents, recombinant DNA, chemicals, chemical inventories, controlled substances, ionizing radiation, non-ionizing radiation, and physical hazards.

Questions shall gather basic information about the research staff and their responsibilities so as to determine the additional training and/or credentialing that may be required. Questions shall be such that the wizard easily directs user to additional forms and/or wizards which will be required as part of the research submission process.

iv. Reportable Event Wizard

1. Shall not repeat any questions already asked as part of any previously used Wizard. Shall request information regarding reportable events as identified by VHA Directive 1058.01 to include, but not limited to, research information security incidents, adverse events, apparent serious and/or continuing noncompliance, protocol deviations, unanticipated problems, etc. Questions shall be such that the wizard easily directs user to additional forms and/or wizards which will be required as part of the research submission process.

v. Application for the Initial and Continuing Use of Animals in Research Study Wizard

1. Shall not repeat any questions already asked as part of any previously used Wizard. Shall request information to include, but not limited to, species, strains, number of animals requested including how many per pain category, experimental design, most severe pain category end point criteria, method(s) of anesthesia and agent(s) used, housing requirements, method(s) of euthanasia, hazardous/infectious agents used and doses, and considerations of reduction, refinement, replacement, etc. Questions shall gather basic information about the research staff and their responsibilities so as to determine the additional training and/or credentialing that may be required. Questions shall be such that the wizard easily directs user to forms and/or wizards which may be additionally required as part of the research submission process.

vi. Application for Science Only Initial and Continuing Review Study Wizard

1. Shall not repeat any questions already asked as part of any previously used

Wizard. Shall request information to include, but not limited to relevance to the VA, the nature of the project, type(s) of data to be analyzed, where data will be stored, who will have access to the data, etc. Questions will identify research staff and shall gather basic information about their responsibilities and training status to determine if additional training and/or credentialing that may be required. Questions shall be such that the wizard easily directs user to forms and/or wizards which will may be additionally required as part of the research submission process.

h. System shall include an online forms and documents library that is accessible to Users and is maintained and easily updated by Customer without requiring technical support from Contractor.

i. Protocol submissions shall have the ability to be routed automatically through the online system for appropriate review and/or action by all required parties to include project staff, research service administration staff, committee reviewers/members, Privacy & Information Security Officers, other ancillary reviewers and Committee chairs. Routing mechanism shall allow simultaneous access to protocol submissions by multiple individuals, allow Customer to determine the sequence of access of individual parties or groups of individuals to the protocol submission, and allow Customer to notify individual parties when a protocol submission is available for their review and/or action.

j. Electronic stamping capability for approved consent forms should be in compliance with VA and OHRP guidelines.

k. Automatic email notifications with customizable text, identification of recipients, and at timelines specified by the Customer for the following:

i. Upcoming expirations for continuing reviews, for R&DC, in-house IRB, IACUC and SRS Committees.

ii. Expiration of personnel qualifications, training, appointment status financial conflicts of interest, and scopes of work.

l. System shall provide details of protocol status at any given time to all affected users.

i. As protocol moves through different steps in the review process, email notification shall be made to the Principal Investigator and to other members of the research team as specified by the Principal Investigator.

m. Tracks all committee membership rosters with dates of expiration of committee appointment and of all relevant training and provides automatic email notices to committee members and committee chair with notice of upcoming expirations.

n. Data tracked for all research staff shall include the following:

i. Name

ii. Credentials (up to four)

iii. Option to capture three email addresses

iv. Study Role (with the ability to have different roles on each study assigned)

v. VA appointment type with expiration date

vi. Scope of work for each study with expiration date

vii. Scope of practice addendum for each study

viii. Identify if working with animals (identify type)

ix. Track animal medical clearance with expirations

x. Identify if working in laboratory or with other hazards

xi. All training records to be linked to research staff and include expiration dates.

1. Direct retrieval of training records from the Collaborative Institutional Training Initiative (CITI).

2. Ability to import relevant records from the VA Talent Management System (TMS) into the system.

3. Ability to manually add training records if not in CITI or TMS.

o. Auditing tools shall be an integral part of the system, identifying edits and reviews of all documents and shall include date/time of any changes as well as identifying the person making the change.

p. The System shall provide for automatic generation of agendas for all committees and subcommittees that meet the following requirements:

i. Options for generation of agenda either by VA-defined rules concerning steps of the review process completed, manual selection, or combination of both processes.

ii. Agendas shall include location, date and time of meeting, anticipated attendees, list protocol number and title, Principal Investigator, type of review, required component reviews, research staff in conflict with any of the review committee members, and shall have a separate function to additional items as needed.

iii. Agendas will allow for addition and tracking of business items

iv. Agendas shall allow for formatting, editing of agenda templates and agendas by committee administrators as needed.

v. Agendas shall allow for pagination.

q. The System shall provide for automatic generation of minutes for all committees and subcommittees that meet the following specifications:

i. Minutes shall list protocol number and title, Principal Investigator, type of review, required component reviews, research staff in conflict with any of the review committee members, discussion, controverted opinions, details of the vote including numbers for, against, recused, and abstaining.

ii. Optional use of minutes templates to ensure all regulatory items are covered.

iii. Inclusion of customizable text to reflect discussion of each business item.

iv. Minutes shall allow editing by committee administrators as needed.

v. Ability to code committee member and investigator names (substitute name with unique number for final minutes of the IACUC).

r. Ability to track and report Events including Serious Adverse Events/Adverse Events

(SAE/AE) with reports to include protocol title, investigator, VAPORHCS location, study intervention, or other VA specification.

s. Automatically generated notification/decision letters with customizable text for all protocols approved by each committee and/or subcommittee as appropriate.

t. System will allow for external documents to be uploaded when signatures are required by VA authorities not set up as Users in system.

u. Data Conversion Kit – Existing protocol data shall be migrated to new system and shall include basic project information to include protocol number, protocol title, current staff, current expiration dates for each committee review, Business Use Agreement or Data Use Agreement if applicable, and type of protocol (one or more of human, animal, or bench). System will allow for administrative upload of all current documents.

v. Contractor shall lead a kick off meeting NLT 60 days after contract execution and shall provide a detailed plan for system rollout based on the current practices and needs of the VA.

i. Contractor shall provide onsite training and support during the configuration process that is specifically targeted for the Research Service Administration Staff which deals with initial set up, applications and use of system.

ii. Provision of user manual

iii. Contractor will provide assistance in configuration and implementation.

iv. Additional training will be provided via either onsite or live Webinar as follows:

1. To accommodate varying schedules, training to PI’s and research community on system use and submission of research protocols will be offered at least twice, with dates to be determined by VA, who will provide a minimum of 30 days’ notice to Contractor. Per training cost provided in contract.

a. Webinar training to be provided as needed, but at least 3 sessions, with ability to schedule additional sessions per contract price. Training to each of the committees on system use and review of research protocols will be offered with dates to be determined by VA, who will provide a minimum of 30 days’ notice to Contractor.

w. Customer support shall be offered M-F from 7:00am to 7:00pm Pacific Time, excluding federal holidays.

x. System shall provide Customer the ability to directly query the underlying database/tables through a third party reporting tool.

y. Upon termination of this agreement, the vendor will provide a copy of all data in appropriate, readable format. If applicable, vendor will provide data in a format to allow for expeditious data migration.

C. Records Management Language for Contracts Required

1. The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract:

a. Citations to pertinent laws, codes and regulations such as 44 U.S.C. chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

b. Contractor shall treat all deliverables under the contract as the property of the U.S.

Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

c. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

d. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

e. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

f. The Government Agency owns the rights to all data/records produced as part of this contract.

g. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the Agency to use the data.

h. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

i. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

j. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

Required Security Information from Appendix B & C

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.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

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

3. VA INFORMATION CUSTODIAL LANGUAGE

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

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

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.

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 (140-2), 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, 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 preapproved 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. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident

7. LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/ subcontractor processes or maintains under this contract. However, it is the policy of the VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in the amount determined to be adequate by the agency.

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

Failure to cooperate may be deemed a material breach and grounds for contract termination.

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

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

(2) Description of the event, including:

(a) date of occurrence;

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

(3) Number of individuals affected or potentially affected;

(4) Names of individuals or groups affected or potentially affected;

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

(6) Amount of time the data has been out of VA control;

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

(8) Known misuses of data containing sensitive personal information, if any;

(9) Assessment of the potential harm to the affected individuals;

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

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

d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $_37.50_ per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(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.

8. SECURITY CONTROLS COMPLIANCE TESTING

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract.