P09 PWS - Medialab VISN 1.docx

Performance Work Statement Continuing Education, Competency Assessment, Document Control for VISN 1 A. Introduction – The VA Medical Centers VISN 1 Pathology and Laboratory Medicine Service (PLMS) has a requirement for document control, continuing education and competency assessment of Laboratory Professionals.

B. Background /Objective - VISN 1 Facilities are currently seeking software to provide document control, continuing education and competency. VA aims to be the provider of choice of veterans and the community by offering an efficient, integrated quality health care system capable of providing a full range of primary, specialty and chronic health care services in a system that is readily accessible and responsive to change. A pivotal part of laboratory operations is the ability to maintain accreditation and the standards set forth by their accrediting bodies and the National VA Pathology and Laboratory and Medicine Service. Current accreditation agencies include: College of American Pathologists (CAP), Joint Commission (JC), Clinical Laboratory Improvement Amendments (CLIA), and American Association of Blood & Biotherapies (AABB). This software will be used for continuing education, competency assessment, and document control as required by all accrediting bodies for PLMS. A large part of maintaining accreditation is CAP’s mandate to maintain document control of all Standard Operation Procedures (SOPs) in pathology and laboratory medicine. It is most effective, efficient and thorough when dedicated when centralized, with the ability to coordinate new documents through various levels.

C. VISN 1 Sites to be included:

As requirements change, facilities within VISN 1 may be added or deleted by supplemental agreement of the Government and the Contractor.

VA Connecticut Healthcare System West Haven Campus 950 Campbell Avenue West Haven, CT 06516 VA Connecticut Healthcare System Newington Campus 555 Willard Ave.

Newington, CT 06111

VA White River Junction 215 North Main Street White River Junction, VT 05009-001 VA Manchester 718 Smyth Road Manchester, NH 03104

VA Providence 830 Chalkstone Avenue Providence, RI 02908 VA Maine 1 VA Center Augusta, ME 04330

VA Boston Healthcare System West Roxbury Campus 1400 VFW Parkway West Roxbury, MA 02132 VA Central Western Massachusetts Healthcare System Northampton Campus 421 North Main Street Leeds, MA 01053

VA Boston Healthcare System Brockton Campus 940 Belmont Street Brockton, MA 02301 VA Bedford Healthcare System 200 Springs Road Bedford, MA 01730

VA Boston Healthcare System Jamaica Plain Campus 150 S. Huntington Avenue Boston, MA 02130

D. Period of Performance – Base year plus 4 option years

E. Scope of Work

1. General

a. Internet / Cloud based application, laboratory software with redundant servers and accessible from any computer 24/7, 365 days/year. Offer must be a SaaS application authorized by FedRAMP

b. For those sites who already have documents in place, those documents must be transferred by the vendor to this new system.

c. The system will include different levels of access based on each site and their needs to access documents.

d. The system must include:

1. Secure documents, passwords, and personal information using encryption and Secure Sockets Layer (SSL). Traffic and data in motion is secured and encrypted with HTTPS / SSL. Data at rest encrypted with FIPS 140-2 compliant encryption methods, such as AES 256, to maintain privacy and confidentiality.

2. Provide system server backup and contingency to ensure access to documents during planned or unplanned downtime.

3. Be Section 508 compliant, Simple and intuitive, menu-driven, customizable portal or user interface.

4. Use already established VA employees’ log on credentials.

5. Modular software components that can be added or removed without requiring major upgrades or changing the functionality of the system.

6. Multiple role or group-based permission levels that enable different levels of user access.

7. The system shall enable easy addition and removal of user and level of access.

8. Total traceability – tracks who performed what steps of task or approval.

9. Easy management of the entire life cycle of a document (create, edit, approve, issue and archive).

10. Set priority tasks and reminders. Assign to self or other users.

11. Customizable workflows based on department or level of importance.

12. Ability to view documents.

13. Ability to create customizable reports.

14. Ability to download full back-ups on demand.

15. Generates site usage reports allowing some determination of system effectiveness.

16. Fast supported implementation.

17. Upgrade/Updates: Vendor must provide and assist with implementation of updates to the service software in order to maintain the integrity of the system and the state-of –the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers.

18. System updates that enhance the model of service being offered, i.e., new versions of software, correction of software defects, updates offered to commercial customers at no additional charge, upgrade to replace model of service no longer vendor supported, etc.

19. Ability to secure documents, passwords, and personal information using encryption and Secure Sockets Layer (SSL), Single Sign On capability. Traffic and data in motion is secured and encrypted with HTTPS / SSL. Data at rest encrypted with FIPS 140-2 compliant encryption methods, such as AES 256.

20. Middleware system must be compliant with all Office of Information and Technology and Information Security Directives and must in compliance with all VA security.

21. If required, any vendor selected must undergo One-VA Technical Reference Model (TRM) approval. It is also expected that the selected vendor will assist in creating and agree to a Memorandum of Understanding MOU-ISA if required.

2. Key Features/Salient Characteristics

a. Document control

1. The document control system must: Allow documents to be uploaded as Word Docs, Excel files, Power Point files, or PDF files.

2. Track all changes made to uploaded documents.

3. Allow the creation of approval processes.

4. Send automatic notifications to approving officials and to employees when documents need to be signed.

5. Send notifications to supervisors if employees do not sign documents within established timelines.

6. Record annual or biennial reviews with electronic signatures.

7. Allow users to flag documents that need revision.

8. Use hashing, encryption, and SSL so that documents, passwords, and personal information stay secure.

9. Have the ability to archive or retire old versions of documents.

b. Inspection Proof

1. Allow users to upload inspection checklists.

2. Allow users to link policies and procedures to checklist items.

3. Allow administrators to delegate checklists or items to other users.

4. Allow for on-site, self-inspections, mock inspections.

5. Allow administrators to approve or reject checklist responses.

6. Allow capture and respond to identified deficiencies.

7. Allow checklist responses to copy to next year’s checklists.

c. Compliance & Continuing Education (CE)

1. User Friendly

2. 24/7 Availability for employees

3. Include OSHA safety courses covering bloodborne pathogens, chemical hygiene, electrical and fire safety, and formaldehyde.

4. Include continuing education courses in hematology, chemistry, phlebotomy, immunohematology/blood bank, immunology, parasitology, virology, toxicology, urinalysis, serology, microbiology, molecular pathology, Point-Of-Care Testing (POCT), lab management, and quality control that awards CAP or P.A.C.E credits for certification and competency maintenance.

5. Allow users to print certificates of completion.

6. Allow users to print reports on training history.

7. Allow administrators to create custom continuing education courses.

8. Allow administrators to assign courses with due dates.

d. Histology Compliance & CE:

1. Include continuing education course in histology and cover special stains, Immunohistochemistry, and Fluorescence in Situ Hybridization (FISH).

2. Include formaldehyde safety and ergonomics courses.

3. Allow users to print certificates of completion.

4. Allow users to print reports of training history.

5. Allow administrators to create custom continuing education courses.

6. Allow administrators to assign courses with due dates.

7. 24/7 Availability for employees

e. Compass Case Simulators:

1. Must provide a wide array of case simulations across all fields of laboratory medicine. Included but not limited to Hematology, Urinalysis, Chemistry, Microbiology, Blood Bank, Anatomic Pathology.

2. Provide realistic case simulations

3. Provide prep exams for Medical Laboratory Scientist, MLS, Medical Laboratory Technician, MLT, Histotechnician, HT, Histotechnologist, HTL and Phlebotomists.

3. The requirement will include:

4.

Base Requirements

12 Months

12 Months

12 Months

12 Months

12 Months

Option Periods 1 through 4

12 Months

12 Months

12 Months

12 Months

12 Months

5. System Support and Maintenance

a. Support (phone, email) must be available on weekdays during normal business hours (8am-5pm EST)

b. Minimal server maintenance.

c. Document backups available to staff during downtimes.

d. Advance notification during server updates or down times.

e. Storage capacity to archive all document types and workflow histories for at least 5 years after removal from use to meet the more stringent transfusion medicine and quality documents requirement is preferred. Alternatively, a minimal storage capacity is needed for archiving transfusion service documents and review/approval histories for 5 years, and other laboratory section records for 2 years.

f. The information system solution selected by the Vendor shall comply with the Federal Information Security Management Act (FISMA) and have a current VA authorization.

g. The contractor shall comply with Federal Risk and Authorization Management Program (FedRAMP) requirements as mandated by Federal laws and policies, including making available any documentation, physical access, and logical access needed to support this requirement.

h. The contractor shall, where applicable, assist with the VA Authority to Operate (ATO) Sustainment Process to help maintain health and quality of agency authorization of the cloud service or migrated application.

i. The contractor shall provide access to FedRAMP authorized and VA authorized. environment.

j. The contractor shall afford VA access to the contractor’s Cloud Service, Provider’s (CSP) facilities, installations, technical capabilities, operations, documentation, records, and databases.

k. If new or unanticipated threats or hazards are discovered by either VA or the contractor, or if existing safeguards have ceased to function, the discoverer shall immediately bring the situation to the attention of the other party in accordance with the security addendum B.

l. The contractor shall not release any data without the consent of VA in writing. All requests for release must be submitted in writing to the Contracting Officer’s Representative (COR)/Contracting Officer (CO).

m. In order for live VA data to be used in this system, access must be provided. to the FedRAMP Authorized and Agency Authorized environment.

n. Under the existing ATO, the contractor shall only allow VA customers to purchase the contractor Federal Licenses.

o. The contractor shall restrict VA customers from purchasing licenses that are not contractor Federal licenses unless there is sign-off from VA Executive Leadership or DTC modifies the current ATO use case.

6. TRAINING AND SUPPORT

p. Contractor shall provide training via online training, through documents or webinar sessions on functionality of solution based on user level.

q. B. The contractor shall provide technical support for platform functionality to users through phone or email communications. Expected response time is 48 business hours.

7. Security Requirement for Cloud Services

a. Per the Office of Management Budget (OMB), any cloud services that hold federal data must be authorized by the Federal Risk and Authorization Management Program (FedRAMP). All Federal data must be stored on a FedRAMP authorized systems, and loss of FedRAMP authorization is equivalent to the inability to house federal data via a cloud service. FedRAMP authorization applies to all third parties and sub-vendors that the vendor uses to store federal data. Proof of FedRAMP authorization must be provided, and the vendor must disclose where all data is stored. If any data is stored by a third party and/or sub-vendor, the vendor must provide proof of FedRAMP authorization for these third parties and sub- vendors. FedRAMP authorization must always be maintained by the vendor and all third parties and subcontractors the vendor uses to store federal data.

b. All cryptographic modules and hardware security modules (HSMs) must be FIPS 140-2 certified. The vendor must provide proof of FIPS 140-2 certification via a NIST approved validator. The operating platform upon which the FIP 140-2 certification was obtain must be maintained.”

8. VA Information and Information System Security/Privacy

a. General Information: Vendors, vendor personnel, sub-vendors, and sub- vendor 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.

b. The vendor shall grant access according to vendor’s specifications while maintaining federal, and local safety standards. The access must be granted within 30 days after contract is awarded. All work shall be completed between 7:30a.m. and 4 p.m. Monday – Friday. All federal holidays, excluded. Federal holidays are available at the. If there is an operational conflict with access, night or weekend access can be an option. Government will provide a 72 hours' notice of change of installation hours. Vendor shall provide an implementation plan, with timelines, and coordinate the initial conversion of all documents into the system if required. The vendor shall provide initial training via TEAMS, WebEx or any form of online training and continued support for all system users at different levels.

9. Training Contractor shall provide initial training via any form of online training and continued support for all system users at different levels.

FEDERAL RISK AND AUTHORIZATION MANAGEMENT PROGRAM (FEDRAMP)

MediaLab is FedRAMP Authorized and VA Authorized. The Contractor shall work with the national FedRAMP assigned point of contact and national VA Business Owner to maintain all requirements and deliverables under the FedRAMP program for VHA.

1. The information system solution selected by the Contractor shall comply with the Federal Information Security Management Act (FISMA) and have a current VA authorization.

2. The Contractor shall comply with FedRAMP requirements as mandated by Federal laws and policies, including making available any documentation, physical access, and logical access needed to support this requirement.

3. The FedRAMP Authorization level and existing VA ATO shall be no less than the level required for this use case which has been defined as Moderate.

4. The Contractor shall, where applicable, assist with the VA ATO Sustainment Process to help maintain health and quality of agency authorization of the cloud service or migrated application.

5. The Contractor shall exclusively provide licenses and/or accounts to FedRAMP authorized and VA authorized environments.

6. The Contractor shall afford VA access to the Contractor’s and Cloud Service Provider’s (CSP) facilities, installations, technical capabilities, operations, documentation, records, and databases.

7. If new or unanticipated vulnerabilities are discovered by either VA or the Contractor, or if existing safeguards have ceased to function, the discoverer shall immediately bring the situation to the attention of the other party, VA Information and Information System Security/Privacy Language. VA Privacy and Security deliverables as directed by the VA System owner.

8. The Contractor shall comply with data management requirements.

9. Successful issuance/maintenance of a VA ATO is required before live VA data can be used in the system.

10. The Contractor shall participate in FedRAMP Continuous Monitoring activities as outlined by FedRAMP’s Continuous Monitoring Strategy Guide found on the FedRAMP Website.

11. The Contractor shall participate in monthly Agency and FedRAMP Sustainment meetings following the granting of a VA ATO.

12. The Contractor shall provide a monthly inventory report of VA sites currently utilizing the cloud product post ATO award to the national VA Business Owner. The inventory report will include the number of licenses being utilized and the specific VA site

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

SECTION 508 – INFORMATION AND COMMUNICATION TECHNOLOGY (ICT) STANDARDS

The Section 508 standards established by the Access Board are incorporated into, and made part of all VA orders, solicitations and purchase orders developed to procure ICT. These standards are found in their entirety at: Revised 508 Standards and 255 Guidelines (access-board.gov). A single PDF file version of the Revised Section 508 Standards and 255 Guidelines will be supplied upon request, or can be obtained from the Access Board website. Federal agencies must comply with the Rehabilitation Act of 1973, as amended.

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

COMPATABILITY WITH ASSISTIVE TECHNOLOGY

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

ACCEPTANCE AND ACCEPTANCE TESTING

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

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

VA TECHNICAL REFERENCE MODEL

The Contractor shall comply with the VA OIT Technical Reference Model (VA TRM). Compliance with the VA TRM is achieved by using only technologies and standards that are listed as approved for use in the VA TRM. The Contractor shall provide all necessary information requested by VA to ensure TRM approval is obtained prior to use on VA’s network.

ZERO TRUST – VA CRITICAL SECURITY CONTROLS

VA has established minimum mandatory security requirements and requires that any network connected software system or service must meet the VA Critical Security Controls as outlined in the VA Memorandum, “VA Security Controls”, https://www.voa.va.gov/DocumentView.aspx?DocumentID=5010. VA Critical Security Controls identify the minimum mandatory requirements that must be implemented across all VA enterprise infrastructure, cloud computing environments, information systems, networks, and specialized devices (medical devices/systems, special-purpose systems, and research scientific computing devices) that process, store, and/or transmit VA data. Effective July 1, 2025, the Contractor shall implement these VA Critical Security Controls, within any network connected software system or service prior to being authorized for use in the VA. This functional requirement is not negotiable, and Plan of Action & Milestones (POAM) will not be accepted in the event these controls cannot be implemented for new systems. Critical Security Controls are intended to increase VA’s security posture and provide security and privacy risk visibility into the VA network and is not a new requirement. The Contractor’s failure to maintain these VA Critical Controls after implementation will result in VA discontinuing the use of the system.

SOCIAL SECURITY NUMBER (SSN) REDUCTION

The Contractor solution shall support the Social Security Number (SSN) Fraud Prevention Act (FPA) of 2017 which prohibits the inclusion of SSNs on any document sent by mail. The Contractor support shall also be performed in accordance with Section 240 of the Consolidated Appropriations Act (CAA) 2018, enacted March 23, 2018, which mandates VA to discontinue using SSNs to identify individuals in all VA information systems as the Primary Identifier. The Contractor shall ensure that any new IT solution discontinues the use of SSN as the Primary Identifier to replace the SSN with the Integrated Control Number (ICN) in all VA information systems for all individuals. The Contractor shall ensure that all Contractor delivered applications and systems integrate with the VA Master Person Index (MPI) for identity traits to include the use of the ICN as the Primary Identifier. The Contractor solution may only use a Social Security Number to identify an individual in an information system if and only if the use of such number is required to obtain information VA requires from an information system that is not under the jurisdiction of VA.

INTERNET PROTOCOL VERSION 6 (IPV6)

The Contractor solution shall support Internet Protocol Version 6 (IPv6) based upon the memo issued by the Office of Management and Budget (OMB) on November 19, 2020 (https://www.whitehouse.gov/wp-content/uploads/2020/11/M-21-07.pdf). IPv6 technology, in accordance with the USGv6 Program (https://www.nist.gov/programs-projects/usgv6-program/usgv6-revision-1), NIST Special Publication (SP) 500-267B Revision 1 “USGv6 Profile” (https://doi.org/10.6028/NIST.SP.500-267Br1), and NIST SP 800-119 “Guidelines for the Secure Deployment of IPv6” (https://doi.org/10.6028/NIST.SP.800-119), compliance shall be included in all IT infrastructures, application designs, application development, operational systems and sub-systems, and their integration. In addition to the above requirements, all devices shall support native IPv6 and dual stack (IPv6 / IPv4) connectivity without additional memory or other resources being provided by the Government, so that they can function in a mixed environment. All public/external facing servers and services (e.g. web, email, DNS, ISP services, etc.) shall support native IPv6 and dual stack (IPv6 / IPv4) users and all internal infrastructure and applications shall communicate using native IPv6 and dual stack (IPv6 / IPv4) operations.

TRUSTED INTERNET CONNECTION (TIC)

The Contractor solution shall meet the requirements outlined in Office of Management and Budget Memorandum M-19-26, “Update to the Trusted Internet Connections (TIC) Initiative“ (https://www.whitehouse.gov/wp-content/uploads/2019/09/M-19-26.pdf), VA Directive 6513 “Secure External Connections”, and shall comply with the TIC 3.0 Core Guidance Documents, including all Volumes and TIC Use Cases, found at the Cybersecurity & Infrastructure Security Agency (CISA) (https://www.cisa.gov/publication/tic-30-core-guidance-documents.)

INFORMATION SECURITY CONSIDERATIONS:

The Assessment and Authorization (A&A) requirements do not apply and a Security Accreditation Package is not required All VA sensitive information shall be protected at all times in accordance with local security field office System Security Plans (SSP’s) and Authority to Operate (ATO)’s for all systems/LAN’s accessed while performing the tasks detailed in this Product Description.

a. A prohibition on unauthorized disclosure: “Information made available to the Contractor or Subcontractor by VA for the performance or administration of this contract or information developed by the Contractor/Subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA.” This clause expressly limits the Contractor/Subcontractor’s rights to use data as described in Rights in Data – General, FAR 52.227-14(d).(1).

b. A requirement for data breach notification: Upon discovery of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the Contractor/Subcontractor has access, the Contractor/Subcontractor shall immediately notify the COR and simultaneously, the designated ISO, and Privacy Officer for the contract. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. See VA Handbook 6500.6, Appendix C, paragraph 6.a.

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

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

1. Notification;

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

3. Data breach analysis;

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

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

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

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

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

VA Records, Privacy and Security Information:

VAAR (VA Acquisition Regulation) clause:

All contractors and subcontractors shall comply with conditions specified in VAAR 852.204-71(d); Contractor operations required to be in United States. All contractors and subcontractors working with VA information must be permanently located within a jurisdiction subject to the law of the United States or its Territories to the maximum extent feasible. If services are proposed to be performed abroad the contractor must state where all non-U.S. services are provided. The contractor shall deliver to VA a detailed plan specifically addressing communications, personnel control, data protection and potential legal issues. The plan shall be approved by the COR/CO in writing prior to access being granted.

Privacy Language for Statement of Work (SOW) Contactor policies and procedures shall comply with all VA Privacy & Security, the Privacy Act and Health Insurance Portability and Accountability Act (HIPAA).

NARA Language - Records Management Language for Statement of Work (SOW):

The following standard items relate to records generated in executing the contract and shall be included in a typical procurement contract:

1. 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.

2. 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.

3. 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.

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

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

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

7. 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.

8. 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.].

9. 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.

10. 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.

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.

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 shall 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.

(1) 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

(2) 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 _15_ 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 _15_ 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.