P09 PWS 1.15.2025.pdf

Performance Work Statement

AHBPCE – Post-Deployment Cardiopulmonary Evaluation Network (PDCEN) Control Group and Repository

General

1.1. Introduction:

The Airborne Hazards and Burn Pits Center of Excellence (AHBPCE) are congressionally tasked with four primary areas of responsibility. This contract specifically addresses the first area: “Performing research related to Veterans’ concerns about exposure to Airborne Hazards and Open Burn Pits”; as well as directly informs the third area: “Delivering specialized clinical care and consultation for Veterans”.

1.2. Background /Objective:

This contract specifically seeks to enhance a ‘control group’ for the VA’s Post- Deployment Cardiopulmonary Evaluation Network (PDCEN). Creating a ‘control group’ is essential because it provides a true baseline of cardiopulmonary health and exposures against which the deployment-exposed, symptomatic Veterans being evaluated clinically can be compared. This allows our clinicians to distinguish which abnormalities and outcomes are specifically associated with deployment-related airborne hazards versus those that reflect background risk in similar Veterans without those exposures or symptoms.

This particular contract builds upon the success of the initial PDCEN Control Group and Repository project contract. For this new contract, we are seeking to have the contractor recruit and test a second group of ‘controls’ comprised 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 non-deployed.

These participants must be free from any symptoms and/or diseases thereby enhancing robust repository data.

The Contractor must have extensive knowledge and expertise in the assessment and management of pulmonary diseases that are due to environmental and occupational exposures and must already have in place established procedures and protocols to acquire the human cardiopulmonary physiology needed by AHBPCE to build its repository data.

The Contractor must adhere to a strict protocol approved by the AHBPCE 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.

1.3. Place of Performance – The services and activities described will take place at the Contractor’s location.

1.4. Period of Performance – The estimated period of performance is for a Base Year, and two one-year options.

Period of performance is as follows:

Base year: 01/15/2026 - 01/14/2027 Option Year 1: 01/15/2027 - 01/14/2028 Option Year 2: 01/15/2028 - 01/14/2029

The contractor shall complete enrollment, testing, and transfer of data by the end of the performance period. Due to the nature of human subjects’ research, there are no interim requirements.

1.5. Recognized Holidays: Contractor is not required to perform services on holidays.

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Juneteenth Christmas Day Independence Day

2. 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

3. Scope of Work

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

• Regulatory Approvals and Oversight: 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. Regulatory approvals may only include modification of existing institutional approvals.

• Recruiting, Screening and Enrollment of Participants: Apply clear and appropriate strategies for recruiting participants established by the AHBPCE. Establish clear eligibility criteria for participants and materials to screen potential participants for eligibility. Execute recruitment strategies, conduct screening to ensure inclusion/exclusion criteria are met, and formally enroll participants into the study.

• Collection, storage, and transfer of cardiopulmonary physiological data: The Contractor shall implement and follow local standard operating procedures for the collection and proper storage of data from volunteers pursuant to best practices established by AHBPCE’s PDCEN. After quality control and anonymization procedures, the Contractor should be capable of transferring data through VHA approved methods to the AHBPCE.

4. Specific Tasks

Task 1: Project Management, Communication, and Progress Reporting

Deliverables for Task 1: a) completion of kick-off meeting, b) attendance and participation in monthly project meetings, c) monthly status updates prior to monthly meeting, and d) bi-annual reports.

General Items for Task 1: The Contracting Officer Representative (COR) will be the vendor’s contact for any administrative or financial communication regarding this contract.

However, the Contracting Officer the only one that can authorize and approve any changes.

The VA Project Manager (PM) and Subject Matter Experts (SMEs) will be the vendor’s contacts for any technical aspects of this contract.

4.1.1 The Contractor must work with the COR to schedule a Project Kick-Off Meeting with the VA PMs and project advisory group comprised of key stakeholders and SMEs to be identified by the VA PMs. Kick-off must occur within 10 calendar days of award. Meeting will be hosted by VA PMs to allow for recordings and contractor will present overview via PowerPoint slides,

4.1.2 The Contractor must attend and participate in monthly project meetings to provide status updates regarding project administration, recruitment, and any troubleshooting.

Additional ad-hoc meetings may be requested (up to 2 additional meetings per month) by AHBPCE leadership. For non-local staff, travel to these meetings will not be approved, and a videoconference (i.e., MS Teams) link number will be provided.

4.1.3 The Contractor must prepare status updates covering primary areas of project (e.g., regulatory/administrative, recruitment/enrollment, data acquisition and processing) and send to VA PMs via email at least 24 hours in advance of monthly meeting.

4.1.4 The Contractor must provide bi-annual (6- and 12-month) progress report to the COR and/or designees including a narrative review of work accomplished during the reporting period, significant events (e.g. regulatory infractions), problem areas (e.g., poor recruitment of participants), milestones obtained or missed, anticipated activity for the next reporting period, and other relevant information as necessary. Report should be provided via email to the COR and/or designees and be received prior to a scheduled monthly meeting.

Task 2: Regulatory Approval and Oversight

Deliverables for Task 2: a) design and/or modification of research-related documents, b) acquisition of institutional approval of all research protocol, consent forms, and associated documents, b) secure approval by AHBPCE SMEs of all research documents and agreements, and c) provide copies and documentation of local approvals (e.g., initial and continuing reviews, audit findings, etc.).

Regulatory Requirements for Task 2: The Contractor’s institution must have an Institutional Review Board (IRB) that complies with the requirements of the Department of Health and Human Services (HHS) Protection of Human Subjects regulations, 45 CFR part 46. This follows that the Institution will have an active Federal wide Assurance (FWA) throughout the duration of this contract. The Contract must use all institutionally approved templates for all regulatory documents.

Milestones for Task 2: The Contractor will have secured institutional approval for the research study within the first 30 days and transferred over all approval documents to VA

PM.

4.2.1 The Contractor must adapt or modify an existing research protocol, or create a new research protocol, in collaboration with AHBPCE PDCEN SMEs, to answer research questions of relevance to Veterans with airborne hazards concerns and feasible in collaboration with ongoing clinical and research activities of AHBPCE. This protocol and related forms (e.g. informed consent form) will be submitted to local institutional review boards and relevant committees within 30 days of the start of the performance period.

4.2.2 Prior to initiating recruitment, the Contractor must submit to the VA PM electronic copies of all institutionally approved protocols, consent forms, recruitment scripts and any other associated regulatory documents (e.g., Data Use Agreements) for review and concurrence by the VA PM.

4.2.3 Final electronic copies of all approved research documents must be emailed to the VA PM for storage.

4.2.4 During monthly meetings and bi-annual reports (described under Task 1), the Contractor must include comments pertaining to regulatory oversight. This may include notification of any changes to regulatory documents (e.g., amendments), initial/continuing review approvals, results of internal audits/reviews, and any other associated regulatory documentation.

Task 3: Recruiting, Screening and Enrollment of Participants

Deliverables for Task 4: a) development, modification and execution of a recruitment plan,

b) screening an estimated 50-100 participants per year, and c) enrollment of 25 participants who meet eligibility criteria.

Milestone: To achieve an enrollment of 25 participants, enrolling 6-7 participants per quarter will be necessary. At the mid-way point of the performance period – enrollment of 12 participants will be considered a successful milestone.

4.3.1 The Contractor must develop clear and appropriate strategies tailored towards recruiting Veteran participants in collaboration with AHBPCE PDCEN SMEs drawing largely from their regional area. These strategies may include recruitment through the affiliated VA hospital (using electronic health record data to target potential Veteran participants), utilizing the VA’s Airborne Hazards and Open Burn Pit Registry and targeting regional Veterans, working with local Veterans Service Organizations to advertise for the study, and utilizing other resources available through the University (e.g., ResearchMatch.org). These strategies must be documented within the protocol and local standard operating procedures (SOPs) and sent electronically to VA PM for approval (as described in Task 2). Recruitment strategy must be aligned with AHBPCE established eligibility criteria. This is a recurring task that will occur throughout the performance period following receipt of regulatory approval and requires status updates at monthly meetings (Task 1).

4.3.2 The Contractor must develop screening scripts and supporting documentation to facilitate accurate and efficient Veteran-centric recruitment and screening. These will be approved by appropriate regulatory entities and reviewed for concurrence by the VA PM (Task 2).

4.3.3 Utilizing phone, email, or other approved communication methods (e.g., SMS/MMS), the Contractor must execute the recruitment strategy and perform screening on an estimated 50 – 100 participants in order to achieve the desired recruitment target of 25 enrolled.

4.3.4 The Contractor must enroll 25 volunteers into the approved protocol during initial contract period (year one). If renewed, the same enrollment target (n = 25) will be expected for option years.

Task 4: Collection, storage, and transfer of cardiopulmonary physiological data

Deliverables for Task 4: a) completion of all study procedures on 25 participants, b) post-processing and quality review of all data elements obtained, c) ensuring electronic data are coded but that all other identifiers have been removed, and d) transfer of all electronic data through secure means to VA PM.

Milestones for Task 4: a) complete data for all procedures for >80% of participants, b) all electronic data are post-processed and quality controlled prior to transfer, and c) transfer of all available data by the end of the performance period.

Data Rights: A copy of the data collected by the Contractor will be transferred directly to the VA PMs and stored at the AHBPCE. These data will be retained within a data repository that is housed at the AHBPCE.

4.4.1 The Contractor must follow protocols and procedures for evaluating cardiopulmonary physiology and obtaining data as defined by AHBPCE PDCEN SMEs and ensure approval for these procedures (Task 3). This is a recurring task that will occur throughout the performance period following receipt of regulatory approval.

4.4.2 The Contractor must ensure completion of all aspects of study protocol, including the recording and acquisition of all data elements outlined in the protocol. Study data must be of sufficient quality (e.g., complete, annotated, and in electronic format) for each participant.

Due to the nature of human subjects’ research, some data loss is anticipated but should not be present in more than 20% of the participant sample. (For example, one or more data elements may be missing or unable to be completed by up to 5 participants).

4.4.3 All data should be inspected to ensure that only the coded study ID is retained on record. Some data may require additional post-processing (e.g., anonymization procedures) to ensure other private health information has been removed.

4.4.4 The Contractor must complete quality control analyses, as defined by VA PMs, on an interim basis and present results at the monthly project meetings (Task 1).

4.4.4 The Contractor shall provide periodic updates on data completeness at monthly project meetings, bi-annual report, and for ad-hoc requests by VA PM (1- 3 per year).

4.4.4 The Contractor must ensure that data are stored locally in accordance with all local regulatory approvals to ensure compliance. Complete data transferred to VA PMs must adhere to U.S. government standards (FIPS 140-2) and/or international ISO standards (FIPS 140-3).

5. Delivery Schedule or Deliverables – Deliverables are outlined above within each Task. Due to the nature of human subjects’ research, deliverables based on enrollment are highly variable (e.g., fluctuate depending on the time of year). Ultimately, the primary deliveries of complete data on 25 participants at the end of the performance period are most important. As described in Task 1 – regular monthly meetings with status updates will allow for monitoring and ensure milestones are being achieved.

Delivery schedule:

5.1 PMP within 10 days of contract kickoff

5.2 Draft research protocol within 7 days of PMP approval; final research protocol within 5 days after receiving government feedback

5.3 Submissions for regulatory approvals within 14 days of PMP approval

5.4 Screening and enrollment of participants upon receipt of regulatory approval, recurring throughout the period of performance

5.5 Collection, storage, and transfer of data in accordance with approved SOPs, recurring throughout the period of performance

5.6 Comprehensive quality control plan delivered within 15 days of contract award, and analyses provided within written reports delivered weekly or according to approved plan

6. 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 resumes 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:

6.1. Principal Investigator (PI): The PI will be responsible for the organization and overall supervision of the project. An experienced investigator within the Pulmonary Division that has an established record of conducting human research that includes evaluating cardiopulmonary physiology.

6.2. Co-Investigator: The Co-Investigator will work alongside the principal investigator to provide organizational and supervisory support for the project. An experienced investigator within the Radiology and Biomedical Imaging Division that has an established record of conducting human research that includes evaluating technology related to cardiovascular disease.

6.3. Post-doc Fellow: The post-doc fellow will assist with protocol development; oversee secure collection, transfer and analysis of data; and conduct quality control and optimization.

6.4. Study Coordinator: A 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 recruiting participants, and obtaining regulatory approvals.

6.5. 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 PWS, 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.

7. Substitution of Key Personnel: All Contractor requests for approval of substitutions hereunder shall be submitted in writing to the COR and the CO at least 30 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 CO 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 CO 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.

8. Quality Control – The Contractor must develop and maintain an effective quality control program to ensure services are performed in accordance with this PWS. The Contractor must develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The Contractor’s quality control program is the means by which he assures himself that his work complies with the requirement of the contract.

9. Quality Assurance – The Government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan. This plan is primarily focused on what the Government must do to ensure that 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 rate(s).

10. Contracting Officer Representative (COR) – The (COR) will be identified by separate letter. The COR monitors all technical aspects of the contract and assists in contract administration. The letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially regarding changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

11. Meetings – Kickoff meeting shall take place within 10 days from award prior to any invoice submission. The Contractor shall participate in monthly project meetings. For non-local staff, travel to these meetings will not be approved and a conference call telephone number will be provided. Contractor shall prepare written status updates as described under Task 1.

12. Required Travel – There is no travel required or necessary to complete these Tasks.

13. Non-Compliance –The Contracting Officer or his/her designee will notify the contractor of any noncompliance with the foregoing provisions and the action to be taken. The Contractor shall, after receipt of such notice, immediately correct the conditions to which attention has been directed. Such notice, when served on the Contractor or his/her representative at the site of the work, shall be deemed sufficient for the purpose aforesaid. If the Contractor fails or refuses to comply promptly, the Contracting Officer may issue an order stopping all and any part of the work and hold the Contractor in default.

14. 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 performance of the work 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 or other VA personnel are authorized to request additional work be performed by the contractor.

Any additional services performed that are not authorized by the contracting officer will be considered inclusive.