PWS - 36C24223Q1002.pdf

Performance Work Statement (PWS)

VA Airborne Hazards and Burn Pits Center of Excellence (AHBPCE)

1. Title: Post-Deployment Cardiopulmonary Evaluation Network Control Group and Repository

2. Purpose: The AHBPCE objective is to procure services from a Contractor that has extensive knowledge and expertise in human clinical research that assesses human cardiopulmonary physiology to advance our understanding of airborne hazards and adverse health effects. The Contractor shall perform a variety of research activities aligned with VHA’s, and AHBPCE’s major initiatives, by developing a clinical research study that allows for the collection, storage and transfer of human cardiopulmonary physiological and related data from human participants for the purposes of serving as a Veteran-relevant control group for the AHBPCE’s Post-Deployment Cardiopulmonary Evaluation Network (PDCEN) and the broader medical community. The Contractor shall also secure all relevant regulatory approvals, recruit participants, collect, store and transfer cardiopulmonary data and biospecimens to support and improve the health and function of our nation’s Veterans. Each deliverable specified herein shall be considered a recommendation for the Government’s approval, with resulting implementation of methodologies upon approval.

3. Background: The Airborne Hazards and Burn Pits Center of Excellence (AHBPCE), located at the New Jersey War Related Illness and Injury Study Center under the program office Health Outcomes Military Exposure– Patient Care Services, was officially recognized by Congress and the President in Public Law 115-929 as a VA Center of Excellence in 2019. Formal designation as the Veterans Affairs AHBPCE by the Deputy Under Secretary for Health for Policy and Services was provided on April 23, 2019. In meeting VHA Directive 1215 (“Standards for VHA Centers of Excellence”) the AHBPCE has four primary responsibility areas that are frequently overlapping. These primary areas include:

1. Performing research related to Veterans’ concerns about exposure to Airborne Hazards and Open Burn Pits;

2. Creating and disseminating high-quality education activities and materials for Veterans and Clinicians

3. Delivering specialized clinical care and consultation for Veterans

4. Monitoring enterprise clinical response through analysis of the VA’s Airborne Hazards and Open Burn Pit

Registry data and related activities.

This contract addresses specifically our first primary responsibility area (“Performing research…”) as well as directly informs our fourth primary responsibility area (“Delivering specialized clinical care…”). Specifically, this contract will enable the AHBPCE to develop critical information through which to compare clinical data from Veterans with deployment-related respiratory disease. The absence of an appropriate control group addresses a significant knowledge gap that has been specifically addressed by the National Academies of Sciences, Engineering and Medicine in their consensus study report, “Respiratory Health Effects of Airborne Hazards Exposures in the Southwest Asia Theater of Military Operations” (2020).

4. Scope: The Contractor must be able to perform a range of clinical research activities including:

• Research Development and Study Design: Design all aspects of research study design and trouble shoot and update study design on a continuous and as-needed basis.

• Regulatory Approvals: Identify all needed regulatory approvals and craft materials and complete and file forms necessary to obtain such approvals at the vendor and VHA. Maintain these approvals and keep meticulous records as required by all oversight entities.

• Recruiting and Screening Participants: Develop clear and appropriate strategies for recruiting participants. Establish clear eligibility criteria for participants and materials to screen potential participants for eligibility. Execute recruitment strategies and conduct screening.

• Collection, storage, and transfer of cardiopulmonary physiological data: The Contractor shall develop clear and appropriate strategies for the collection and proper storage of data from volunteers pursuant https://www.warrelatedillness.va.gov/WARRELATEDILLNESS/AHBPCE/index.asp?msclkid=5ac8593bba7611eca6462346b58b67c8 to best practices established by the AHBPCE’s PDCEN. After quality control procedures, the Contractor should be capable of transferring data through VHA approved methods to the AHBPCE.

• Quality Control and Optimization: Develop and design quality control procedures, perform initial process and procedure testing and optimization, perform and review ongoing quality control procedures throughout the contract period and report results on an appropriate schedule as finalized in the Project Management Plan. Appropriate examples and templates will be provided by the Government upon request.

5. Period of Performance: Base Year 09/01/2023-08/31/2024 and Option Year 1 09/01/2024-08/31/2025

6. Place of Performance: The contract services and activities described will take place at the Contractor’s facility.

7. Contractor’s Task Responsibilities

7.1 Task 1: Project Management and Progress Reporting

7.1.1 The Contractor must provide project management support. A Project Management Plan (PMP) that lays out the Contractor’s approach, timeline and tools shall be provided in the execution of each task order. At the Kick-Off Meeting, the Contractor, program office, and CO shall review the details of the PWS. Work shall not commence until the VA project manager (PM) approves the updated PMP (to be provided by the Contractor to the government no greater than ten (10) days from the kick-off). The Contractor shall also complete standard administrative tasks (e.g., staff roster, mandatory training) as outlined in the base contract and task order.

The Contractor will participate in quarterly contract management meetings. For non-local staff, travel to these meetings will not be approved, and a conference call telephone number will be provided. The Contractor will prepare the meeting agendas and provide summary notes following these meetings. For planning purposes, the meetings will begin three months after the Government exercises.

7.1.2 The Contractor shall use the PMP created in the base year and update as needed. The project plan will include:

• Intended approach and work plan

• Project schedule with deliverable dates with major milestones

7.1.3 The Contractor shall work with the COR to schedule a Project Kick-Off Meeting with the VA Project Manager (PM) and project advisory group comprised of key stakeholders and subject matter experts (SMEs) to be identified by the VA PMs. Kick-off must occur within 30 days of award.

7.1.4 The Contractor shall provide quarterly progress reports. The Contractor shall brief the COR and/or designees as to the status of the project, quality control findings, description of any problems anticipated or encountered and their resolution or non-resolution, and milestones obtained or missed. The Contractor shall keep a log of decisions made during the course of the contract and provide the VA COR with an updated log of any new decisions made following the quarterly meeting within 7 business days following each meeting. After review of the decision log, the VA COR will provide any necessary corrections to the decision log, which then will be revised.

7.1.5 The Contractor shall prepare agendas and minutes for meetings. The Contractor shall take minutes of all conference calls and/or meetings held with the Project Manager, VA COR, and Stakeholders. Copies of these minutes shall be attached to the quarterly progress report.

7.1.6 The Contractor shall provide quarterly reports. These reports should be accompanied by a copy of each month’s invoice itemized by task. The quarterly progress report will include a narrative review of work accomplished during the reporting period itemized by project, and significant events, problem areas, anticipated activity for the next reporting period, description of any travel or unique services provided, and other relevant information, as necessary.

7.2 Task 2: Research Development and Study Design

7.2.1 The Contractor will create a comprehensive protocol to answer research questions of relevance to Veterans with airborne hazards concerns and feasible in collaboration with ongoing clinical and research activities of WRIISC/AHBPCE.

7.2.2 Protocol: The Contractor shall provide an updated draft protocol and upon receiving Government feedback, a final protocol. The draft will be submitted seven (7) days after the PMP is approved.

7.3 Task 3: Regulatory Approvals

7.3.1 The vendor will identify all necessary regulatory oversight entities at VA and the vendor and prepare all documentation necessary to achieve full, expeditious approval, using Government provided templates as needed. All initial submissions should be submitted within fourteen (14) days after the PMP is approved. The vendor shall provide electronic copies of all documents to the Government, track all approvals, and maintain a complete record of all communications with regulatory oversight entities.

The vendor shall complete, at a minimum, the following regulatory approvals and documentation:

• The Contractor Institutional Review Board (IRB) and Research & Development Committees

• Signed and executed Data Use Agreement/Material Transfer Agreements

7.4 Task 4 – Recruiting and Screening Participants

The vendor shall develop clear and appropriate strategies for recruiting participants. Establish clear eligibility criteria for participants and materials to screen potential participants for eligibility. Execute recruitment strategies and conduct screening.

7.4.1 The Vendor will identify strategies for recruiting participants in collaboration with AHBPCE PDCEN SME’s drawing largely from their regional area.

7.4.2 The vendor will develop screening scripts and supporting documentation to facilitate accurate and efficient, Veteran-centric recruitment and screening. These will be approved by appropriate regulatory entities.

7.4.3 The vendor will execute the recruitment strategy and perform screening on up to 100 potentially eligible volunteers.

7.4.4 The vendor will successfully recruit, screen, and enroll up to 25 volunteers into the approved protocol during the initial contract period. If renewed, the vendor anticipates enrolling and additional 25 total eligible volunteers in year two and beyond.

7.5 Task 5 – Collecting Data and Specimens

The vendor will design and develop Standard Operating Procedures (SOPs) for evaluating cardiopulmonary physiology and obtaining data/biospecimens in consultations with AHBPCE PDCEN SME’s. The vendor will execute data and specimen collection in accordance with the developed SOPs.

7.5.1 The vendor will design and document SOPs for acquiring data, sputum, and blood specimens in consultation with WRIISC/AHBPCE SME’s within seven (7) days of completing the review (task 7.5.1).

7.5.2 Throughout the initial contract period, the vendor will ensure the collection of all relevant data and specimens of 25 enrolled research participants.

7.5.3 The vendor that data and specimens are processed and transported in accordance with all regulatory approvals to the location best suited for complete analysis.

7.6 Task 6 – Quality Control and Optimization

The Contractor will develop and design quality control procedures, perform initial process and procedure testing and optimization, perform and review ongoing quality control procedures throughout the contract period and report results on a weekly or every batch basis.

7.6.1 The Contractor will develop a comprehensive quality control plan within thirty (30) days of finalizing the protocol and completing the assessment of WRIISC/AHBPCE capabilities for data and specimen collection and processing. This will be reviewed by the Government and either accepted or returned for modification within seven (7) business days.

7.6.2 The Contractor will complete quality control analyses according to the approved comprehensive quality control plan and report findings in a written report on a weekly or every batch basis.

7.6.3 Any deficiencies (e.g., data loss, inaccuracies detected) or inefficiencies will be corrected immediately, and a corrective plan will be submitted to the Government for review and approval.

7.6.4 All corrective plans will be enacted within seven (7) days or no later than the next data/specimen collection or assay performance, whichever occurs first.

8. Personnel: Certain skilled experience professional and/or technical personnel are essential for accomplishing the work to be performed. These are defined as key personnel and are those persons whose résumés were submitted. The Contractor agrees that the key personnel shall not be removed, diverted, or replaced from work without coordination with the CO and COR. The following labor categories are defined as Key Personnel:

1. Principal Investigator (PI): The principal investigator is a PhD, MD, or equivalent scientist who will be responsible for the organization and overall supervision of the project. They are an experienced investigator (5+ years) with a record of conducting human research that includes evaluating cardiopulmonary physiology.

2. Clinical/Translational Research Coordinator: An advanced study coordinator will be the primary liaison on site at the

Contractor’s site, coordinating the involvement between the Vendor, government staff, and participants. They will be responsible for consenting and recruitment of participants.

3. Research Assistant: Research assistant will be utilized at the contractor’s site to acquire, process, and store data.

They will perform QA/QC analysis on the data/specimen collection and preparation as well as tracking data with samples. This individual will work under the supervision of the research coordinator and PI.

The Contractor shall assign the above-described individuals to perform the work specified at their regular site of employment. These individuals shall be fully qualified and have the level of experience necessary to accomplish the requirements of this SOW, as determined by OPH. Additionally, the Contractor shall be acceptable to the Government in terms of personal and professional conduct, and adhere to the security regulations, policies, and procedures.

10. 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 all necessary security requirements, as defined in Section 15, have been fulfilled and resumes 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.

11. Information Security: The Contractor will not require access to VA Information and VA Information Systems.

Therefore, all Contractors and Contractor personnel shall not be subject to the same Federal laws, regulations, standards and VA policies as VA, and VA personnel, regarding information and information system security.

12. Security: The Contractor will not require access to VA Information and VA Information Systems. Neither background investigations nor security trainings of personnel are required.

13. 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.

14. 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 task 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 tasks and whenever replacement personnel are proposed under an ongoing task.

Acronyms:

AHBPCE: Airborne Hazards and Burn Pits Center of Excellence

CO: Contracting Officer

COR: Contracting Officer Representative

OCI: Organizational Conflict of Interest

PDCEN: Post-Deployment Cardiopulmonary Evaluation Network

PI: Principal Investigator

PM: Project Manager

PMP: Project Management Plan

PWS: Performance Work Statement

SME’s: Subject Matter Experts

SOP: Standard Operating Procedures

VHA: Veteran’s Health Administration

WRIISC: War Related Illness and Injury Study Center