P01 SOW Statistics.docx

1. Title:

Exposure Related Care Transformation Center (EXPRT) and the War Related Illness and Injury Study Center (WRIISC)

2. Purpose:

This procurement is seeking clinical/health informatics expertise to include quantitative support (i.e., data science, ‘big data’ analysis [using the VA’s electronic health record] and statistical analysis of clinical trials in order to provide Veterans, policymakers, providers and researchers with up-to-date information on military environmental exposures. These skills will allow us to expand our program evaluation and research portfolio to ensure that implementation of the PACT Act meets the needs of Veterans and their providers.

3. Background:

The EXPRT Center is located at the New Jersey War Related Illness and Injury Study Center. The EXPRT Center’s mission is to transform care and improve health for Veterans with military exposure concerns by accelerating research into action through education, implementation support, evaluation, and research.

Due to passage of the recent Sergeant First Class Heath Robinson Honoring Our Promise to Address Comprehensive Toxics Act of 2022 (referred as the “PACT act”), there is increasing attention on the need to communicate information, knowledge, and best practices to VA’s providers and Veterans around military environmental exposures. Additionally, a focus on military environmental exposures and related information is increasingly sought by policymakers that need concise and clear competing communications.

4. Scope:

The Vendor shall be able to perform a range of activities to support high quality program evaluation and research (“new knowledge”) deliverables, including: i) gather, assess and synthesize data, scientific, medical technological and policy information from governmental and nongovernmental resources such as universities, private organizations, US Government agencies, international organizations and recognized experts worldwide, ii) maintain VA standards for data privacy and security, iii) perform statistical analysis to include analysis of VA’s electronic health record, iv) facilitation and completion of regulatory documents.

5. Period of Performance:

The period of performance is one 12-month base period and four 12-month option periods. Performance shall start one month following the date of award.

6. Place of Performance:

Work will be performed offsite at the contractor’s facility for successful completion of required deliverables. Virtual meetings will be held at least weekly, along with a project kick-off and close-out meetings, lasting approximately 60 minutes each. Any additional meetings will be scheduled as needed. Meetings will be virtual using the Microsoft Teams or similar platform. Contractor must work within the VA secured electronic environment (Teams, SharePoint, etc.) to facilitate communications.

7. Travel:

Travel to the WRIISC or affiliated sites for meeting support including photography or other collateral as needed. Local travel within a 50-mile radius from the contractor’s and Government facility is considered the cost of doing business and will not be reimbursed.

8. Other Direct Costs (ODCs):

The Government anticipates that ODCs will be required to address the requirements. ODCs are miscellaneous items such as suitable stock photography or printing as needed. ODCs will be reimbursed at contractor cost. Each contractor invoice must include copies of all receipts that support the ODCs claimed in the invoice and written substantiation for the incurred cost. The Contractor shall perform due diligence to ensure it incurs most‐favorable pricing prior to passing these costs on to the Government. Projected ODCs shall be reviewed by COR and authorized in advance by the Contracting Officer.

9. General Requirements:

The deliverables specified herein include administrative, research, and statistical support. Efforts shall include analysis of VA electronic medical record data (i.e., CDW; presentation of statistical findings that are consistent with VA, VHA, and EXPRT/WRIISC strategic plans, policies, regulations, style guides, and publication standards; administrative support for research and evaluation protocols; and qualitative research support consistent with policies, regulations, style guides, and publication standards. The Government will provide clarification on recommendations, requirements, templates, standards, and guidelines on all deliverables when clarification is not provided in this SOW prior to any action taken by the contractor. All work products developed by the contractor (formal and informal deliverables) shall become the property of the Government.

The contractor shall coordinate with the Contracting Officer Representative (COR) to schedule a Project Kick-Off Meeting with key staff; the VA PM and advisory group prior to commencing work. The contractor personnel shall also complete standard administrative tasks (e.g., background investigation forms, staff roster, mandatory training) as required.

The contractor shall prepare and submit progress reports to the COR and the VA PMs. Monthly status reports shall be accompanied by a copy of that month’s invoice itemized by deliverable, as applicable. Progress reports shall include a narrative review of work accomplished during the reporting period itemized by project, significant events, problem areas, anticipated activity for the next reporting period, description of any travel or unique services provided, and other relevant information.

The contractor shall regularly participate in contract management meetings TBD. The contractor shall work with the VA COR to prepare the meeting agenda and prepare summary notes. Meetings will also be held to gather input from subject matter experts (SME), identify their needs, and translate the strategic communication plan into action. Reports, meeting agendas, and draft/final deliverables will be saved and tracked on the VA network using SharePoint and Microsoft Teams.

The contractor shall provide the specific deliverables described below within the performance period of the resulting contract. An outline for each product shall be created for review prior to developing content. All content shall be provided in draft and be subject to two rounds of revisions. Once written content is approved, layout and design can proceed again with two rounds of revisions. Where a written milestone deliverable is required in draft form, the VA COR and lead technical contact will complete a review of the draft deliverable and provide feedback within ten business days from date of receipt. The VA COR will provide approval for each final deliverable, or rejection of the final deliverable with summary reasons in writing within five business days.

10 Tasks

10.1 Task 1: Project Management

10.1.1. The vendor shall develop a project plan that outlines the overall strategic approach to the requested work. The plan should address:

· Deliverables and deadlines

· Resources needed

· Roles and responsibilities

· Monthly progress reports

· Weekly teleconferences VA will review the proposed project plan and return it to the contractor within two weeks with comments and any adjustments that might need to be made. For initial drafts of other deliverables, VA will provide comments within 10 days of draft receipt.

10.2 Task Deliverables: Quantitative Statistical Support

10.2.1 Analysis of VA administrative data to include the electronic health record housed in the Corporate Data Warehouse (CDW) within the VA Informational Computer Infrastructure (VINCI). This requires knowledge of software including ArcGIS, R, SAS, and STATA.

10.2.2 Independently navigates big data systems to create cleaned and linked datasets that can be used to analyze the Centers initiatives and predictive analytics. Independently analyzes big data and translates the findings into recommendations that will advance the work of the Center, VA and other stakeholders to improve care for military exposures.

10.2.3 Work collaboratively and closely with EXPRT/WRIISC SME’s, etc. to develop analysis plans for evaluation protocols and grant applications and provide analysis support for peer-reviewed and internal presentations and publications.

10.2.4 Supports and augments existing research, model development, and education activities being performed by the Center through finding data, interpreting data, and utilizing data, to advance these projects.

10.2.5 Compile and complete regulatory documents for VA Research & Development, Quality Improvement/Quality Assurance, and interface with needed program offices as directed.

11. Personnel: Certain skilled experience professional and/or technical personnel are essential for accomplishing the work to be performed and provide the greatest value. These are defined as key personnel and are those persons the contractor identifies and those whose résumés are submitted. The Contractor agrees that the key personnel roles shall not be removed, diverted, or replaced from work without coordination with the CO and COR. The Contractor’s key personnel shall satisfy the following technical requirements.

A. Data Scientist:

· Master of Science or more advanced degree with emphasis on databases, data architectures, and data structures, algorithms, statistics or equivalent.

· High level of proficiency in software including but not limited to R, SAS, and STATA.

· Experience with NoSQL and SQL databases.

· Expert in statistics.

· Expert in algorithms.

· Strong oral and written communication skills.

· Work is performed with minimal supervision and guidance. Results of work are considered technically authoritative.

12. Substitution of Key Personnel: All Contractor requests for approval of substitutions hereunder shall be submitted in writing to the COR and the Contracting Officer at least thirty (30) calendar days in advance of the effective date, whenever possible, and shall provide a detailed explanation of the circumstances necessitating the proposed substitution, a complete resume for the proposed substitute, and any other information requested by the Contracting Officer necessary to approve or disapprove the proposed substitution. New personnel shall not commence work until resumes are provided and accepted. The COR and the Contracting Officer will evaluate such requests and promptly notify the Contractor of approval or disapproval in writing.

The Contractor shall be responsible for managing and overseeing the activities of all Contractor contracted personnel, as well as sub-contractor efforts used in performance of this effort. The Contractor’s management responsibilities shall include all activities necessary to ensure the accomplishment of timely and effective support, performed in accordance with the requirements contained herein.

13. Information Security: The Contractor will require access to VA Information and VA Information Systems only to interact with subject matter experts, create content (e.g., VA’s web, SharePoint, Teams), and facilitate communication.

14. Security: The C&A requirements do not apply, and a Security Accreditation Package is not required

15. Government-Furnished Information, Equipment, and Facilities. The Government will provide access to information necessary for the execution of each task.

16. Security Requirements. The C&A requirements do not apply, and a Security Accreditation Package is not required

17. Task Order Quality Assurance Surveillance Plan (QASP).

The Government shall evaluate the contractor's performance in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the government must do to ensure the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rates.

The Government shall evaluate the contractor's performance in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the government must do to ensure the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rates.

Project Management Milestones, and Schedule Notifies customer of potential problems 95% of the time.

Submits Deliverables in accordance with the deliverable schedule within (+/-) five business days with no more than five incidents of performance slippage.

100% Inspection of agreed upon milestones per the approved project plan.

100% Inspection of deliverables.

Notification occurs within two business days of potential issue when known in advance or within 24 hours of urgent problems, where less than two business days exist.

18. Organizational Conflict of Interest and non-disclosure requirements If the Contractor is currently providing support or anticipates providing support to the VHA that creates or represents an actual or potential organizational conflict of interest (OCI), the Contractor shall immediately disclose this actual or potential OCI in accordance with FAR Part 9.5. The contractor is also required to complete and sign an Organizational Conflict of Interest Statement in which the Contractor (and any sub-contractors, consultants or teaming partners) agree to disclose information concerning the actual or potential conflict with any proposal for any solicitation relating to any work in the TO. All actual or potential OCI situations shall be handled in accordance with FAR Subpart 9.5.

19. Non-Disclosure Requirements All Contractor personnel (to include sub-contractors, teaming partners, and consultants) who shall be personally and substantially involved in the performance of the TO issued which requires the contractor to act on behalf of or provide advice with respect to any phase of an agency procurement, as defined in FAR 3.104-4, shall execute and submit an “Employee/Contractor Non-Disclosure Agreement” Form. This is required prior to the commencement of any work on such TO and whenever replacement personnel are proposed under an ongoing TO. Any information obtained or provided in the performance of this TO is only to be used in the performance of the TO.

20. 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.