36C26122Q0102 - Attachment 1 Statement of Work.pdf

STATEMENT OF WORK

VA Palo Alto Healthcare System

Project Name: Research Recruitment Advertising Type of Service: Research Service

This is a service contract to support the Palo Alto VA-based NIH grant: 5I01CX002182-02, “The role of the brainstem in GWVI pathology.”

Scope: The purpose of this contract is to obtain participant recruitment assistance. Recruiting participants for research is the most diff icult aspect of a research study and requires a lot of time and resources. Using a third-party vendor to help inform the public of our research study is an invaluable tool for research success. It saves money and time by eliminating the need to hire additional, fulltime salaried employees to handle recruitment. It allows study staff to focus on high-quality data collection, and to use their time to create a comfortable environment for research participants.

The work will include: 1) Development and deployment of custom advertisement campaigns to reach our target audience – Gulf War Veterans across the US, and 2) Give potential participants a secure landing page for our study. The landing page should contain contact information, the study’s purpose, and eligibility requirements – Veterans can sign-up on the landing page, or they can call the research team directly. The contractor must be able to provide at least six months of active advertisement; such advertisement must have the capability to change, update, pause, and resume at any point during the period of performance. In addition, the contractor shall provide support services throughout the period of performance.

In the performance of this work, the contractor will NOT work on VA systems nor have any contact with the VA network. Study staff will NOT be sharing any VA sensitive information with the vendor.

Qualifications: The ideal contractor will have the following qualifications:

- At least 2 years of experience with marketing and research recruitment for VA studies and NIH funded studies

- Knowledge of IRB, RDIS, HIPAA, and general research guidelines and ethical practices

- Demonstrate ability to communicate effectively with research team and be supportive of research evolvement and regulations

- Create high quality web-based interfaces for participants

- Provide user-friendly access to participant sign-ups for the research team

- Willing to complete all required paperwork and documentation requested from VA administration

Deliverables:

(1) Development of custom advertisements. Based on brainstorming meetings with the research team, the contractor will learn about the research study details, requirements, and goals, to produce tailored advertisements that will appeal to the target research population (i.e., Gulf War Veterans). The proposed advertisements will then go through an approval process with research oversight teams (Stanford Institutional Review Board, VA Office of Research Development, and Oversight).

Once approved, the study team will inform the contractor to deploy the advertisements nationwide via social media. The text and images on the approved advertisements cannot be changed without informing the study team.

(2) Deployment of advertisements. The contractor will follow all ethical rules and regulations for proper advertising via social media. This includes meeting deadlines for submission, communicating with social media platforms, abiding by terms and conditions set forth by social media platforms, and monitoring success of advertisements. Study staff will be able to control advertisements by turning the campaign on or off at desired intervals. Advertisements will reach the target audience (Gulf War Veterans) by being linked to Veteran-related pages on social media. Any person who searches for Veteran-related resources, groups, information, entertainment, or social engagement, will be shown the study’s advertisement on their screen. This functions the same way as all internet algorithm marketing strategies.

(3) Obtain appropriate numbers of recruited subjects based on negotiated goals and timeline. The goal is to recruit between 27 – 35 people to participate in the study. If adjustments need to be made to improve advertisement outreach, the contractor will notify study staff immediately to discuss solutions. Any updates made to recruitment and advertisement plan will be sent to the IRB for approval before being disseminated to the public.

Period of Performance: 01/01/22 – 12/31/22

Place of Performance: All work will be completed at the contractor’s place of business.

Payment Method: All invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.

More information on the VA Financial Services Center is available at http://www.fsc.va.gov/einvoice.asp.

Vendor e-Invoice Set-Up Information:

Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge.

If you have question about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below:

• Tungsten e-Invoice Setup Information: 1-877-489-6135

• Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

• FSC e-Invoice Contact Information: 1-877-353-9791

• FSC e-invoice email: vafsccshd@va.gov http://www.tungsten-network.com/US/en/veterans-affairs/ http://www.fsc.va.gov/einvoice.asp

Government equipment furnished: None

Government space furnished: None

Access to VA computer: None

PDAT: The risk of this contractor accidentally releasing any PHI is low. They are not given access to any VA sensitive information.

Inclusion of Statements Per Appendix A (6500.6 Handbook) Instructions (per ISO Direction):

The C&A Requirements do not apply to this purchase and a security accreditation package is not required.

Contractor will not work on VA systems nor have any contact with the VA network.

Section 1: General 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).

Section 2: Access to VA Information and Info Systems No contractor or contractor employee will require access to VA information systems, the VA network, or any PHI-containing VA data at anytime in the course of this work.

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. 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 notif ied immediately by the contractor or subcontractor prior to an unfriendly termination.

d. 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.

e. 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.

f. 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.

Section 3: Custodial Language 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.

The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement.

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.

Section 4: (If Applicable) Info System Design and Development N/A

Section 5: Info System Hosting Contractor will not receive any data from VA systems.

Section 6: Security Incident Investigation At no time will the contractor ever have access to any PHI-containing data from VA systems.

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. Notif ications 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. Known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach.

Notif ications need to be made in accordance with the executed business associate agreement.

Section 7: Security Controls Compliance Testing No PHI will be provided to the contractor at any time in the course of this work.

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

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.

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) Notif ication;

(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 falsif ied or damaged credit records, histories, or financial affairs.

Section 8: Training No contractor or contractor employee will require access to VA information systems, the VA network, or any VA data with PHI in the course of this work.

a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems;

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, VA Handbook 6500.6, Appendix E relating to access to VA information and information systems;

(2). Successfully complete the Privacy and Information Security Awareness and Rules of Behavior training and annually complete required security training;

(3). Successfully complete the appropriate VA Privacy and HIPAA training and annually complete required privacy training; and (4). Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800- 16, Information Technology Security Training Requirements.

b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certif icates and certif ication of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.