PWS INTENT TO SOLE SOURCE.pdf

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

Performance Work Statement (PWS)

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

2. PURPOSE: To build upon the success of the initial Post-Deployment Cardiopulmonary Evaluation Network (PDCEN) Control Group and Repository project, expanding our control group to include a second group of ‘controls’ composed of deployed or non-deployed military Veterans who are free of any symptoms and/or diseases. This requirement focuses exclusively on recruiting military veterans who were deployed or not deployed. These participants must be free from any symptoms and/or diseases thereby enhancing robust repository data.

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 (12HOME) – Patient Care Services (10P4), was officially recognized by Congress and the President in Public Law 115-929 as a VA Center of Excellence in 2019 (H.R. 5895). Formal designation as the Veterans Affairs AHBPCE by the Deputy Under Secretary for Health for Policy and Services (10P) 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 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 with a control group of deployed or non-deployed healthy military veterans who must be free of any symptoms and/or diseases.

The Contractor must already have established procedures and protocols to acquire the human cardiopulmonary physiology needed by AHBPCE to build its repository data.

The Contractor must have 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 must 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 PDCEN and the broader medical community.

The Contractor must also secure all relevant regulatory approvals, recruit participants, collect, store and transfer cardiopulmonary data 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.

The Contractor shall include the following:

https://www.warrelatedillness.va.gov/WARRELATEDILLNESS/AHBPCE/index.asp?msclkid=5ac8593bba7611eca6462346b58b67c8 https://www.congress.gov/congressional-report/115th-congress/house-report/929

• 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 to best practices established by 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 plus two (2) provisional option years. The estimated POP for the base year is 09/14/2025 through 09/13/2026.

6. PLACE OF PERFORMANCE: All services and activities described will take place at the Research Clinic (Contractor’s location).

7. TASKS

7.1 TASK 1: PROJECT MANAGEMENT AND PROGRESS REPORTING

7.1.1 The Contractor shall 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 shall 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 the 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 seven (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 shall create a comprehensive protocol (or amend existing protocols) 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 Contractor shall 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 Contractor 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 Contractor 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 as necessary.

7.3 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.

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

7.3.2 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.

7.3.3 The vendor will execute the recruitment strategy and perform screening on up to 100 potentially eligible volunteers per year for the award (base year and option years if applicable).

7.3.4 The vendor will successfully recruit, screen, and enroll up to 25 qualified volunteers into the approved protocol during each year of the award (base year and option years if applicable).

7.4 TASK 5 – COLLECTING DATA AND SPECIMENS

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

7.4.1 The vendor will design and document SOPs for acquiring data in consultation with WRIISC/AHBPCE SMEs within seven (7) days of completing the review (task 7.5.1).

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

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

7.4 TASK 7 – QUALITY CONTROL AND OPTIMIZATION

The Contractor shall 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.

7.4.1 The Contractor shall 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.

7.4.2 The Contractor shall 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.

7.4.3 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.

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

8. KEY PERSONNEL: Certain skilled 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 shall be responsible for the organization and overall supervision of the project. An experienced investigator within the Pulmonary Division must have an established record of conducting human research that includes evaluating cardiopulmonary physiology.

2. Study Manager/Supervisor(s): The study manager shall be an expert in human clinical studies and the analysis of data from such work. They shall supervise the development of Institutional Review Board (IRB) protocols and applications and their administration as well as the storage and tracking of data within the study.

3. Study Coordinator(s): A study coordinator shall be the primary liaison on site at the Contractor’s site, coordinating the involvement between the Vendor, government staff, and participants. They shall be responsible for consenting and recruiting of participants.

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 AHBPCE. 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 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 training 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.

15. Quality Assurance Surveillance Plan (QASP): The Government will 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.

16. Other Related Services (Not Included in the Scope of Work): Any services not expressly stated in the Performance Work Statement are not authorized. Additional services deemed vital to the continued functioning of the systems or PWS herein may be added only after written modification from the Contracting Officer unless they are inclusive to the requested services. No other person, including the COR, POC, or any other VA personnel are authorized to request additional work to be performed by the Contractor. Any additional services performed that are not authorized by the Contracting Officer shall be considered inclusive and the Contractor shall bear the additional cost for services provided that were not approved by the Contracting Officer.

Acronyms:

AHBPCE: Airborne Hazards and Burn Pits Center of Excellence

CO: Contracting Officer

COR: Contracting Officer Representative

IBR: Institutional Review Board

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