Limiting Sources Justification WRIISC -EXECUTED.pdf

Attachment 2: Request for Limited Sources Justification Format >SAT

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C242-25-AP-0508

(1) Contracting Activity: Department of Veterans Affairs, VISN 02, Samuel S. Stratton VA Medical Center 113 Holland Ave, Albany, NY 12208-3410 procuring the requirement for NJ Healthcare System East Orange VA Medical Center 385 Tremont Ave, East Orange, NJ 07018- 1095 on behalf of using activity WRIISC. 2237 funding ID 561-25-2-2238-0044.

(2) Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501).

The Network Contracting Office (NCO) 2 intends to award a new procurement as a sole source contract to Oak Ridge Associated Universities, Inc (ORAU) a 501(c)(3), a non-for-profit organization using GSA contract GS-00F-195CA.

Order against: FSS Contract Number: GS-00F-195CA

Name of Proposed Contractor:

Street Address:

City, State, Zip:

Phone:

OAK RIDGE ASSOCIATED UNIVERSITIES, INCORPORATED

100 ORAU Way #MS-27 Oak Ridge, Tennessee 37830-6209

(865) 393-1775

(3) Description of Supplies or Services:

The estimated value of the proposed action is $429,688.66.

The Airborne Hazards and Burn Pits Center of Excellence (AHBPCE) at the War Related Illness and Injury Study Center (WRIISC) within the VA NJ Health Care System (East Orange, NJ) requires administrative support for its Pilot Project Peer Review Program (PPP). The Contractor will facilitate the program, assist internal investigators with applications, and provide peer review services. Specific tasks include:

Identifying external subject matter experts to conduct technical peer reviews.

Summarizing and synthesizing the results of peer reviews.

The proposed sole source contract is for a Base Year and three Option Years, Firm-Fixed-Price (FFP). The performance period is for the estimated Base Year from 08/31/2025 through 08/30/2026 with three provisional Option Years from 08/31/2026 through 08/30/2029. The estimated dollar amount for the Base Year and the three Option Years is $429,688.66.

VHAPG Part 808.405-6 Limiting Sources Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C242-25-AP-0508 https://www.acquisition.gov/far/part-8#FAR_8_405_6 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.gpo.gov/fdsys/pkg/USCODE-2011-title40/pdf/USCODE-2011-title40-subtitleI-chap5-subchapI-sec501.pdf

The New Jersey War Related Illness and Injury Study Center (NJ WRIISC) Airborne Hazards and Burn Pits Center of Excellence (AHBPCE) seeks to provide Veterans with an accelerated timeline to address their health concerns. Accordingly, AHBPCE has developed and internally supported a Pilot Project Program (PPP) to foster new ideas and attract new researchers regarding the study of health effects related to military environmental exposure. In order to keep pace with current interest and expand opportunities for investigators, we require specialized research support to:

1. Minimizing biases and conflicts of interest within the current internal review process.

Expanding the pool of eligible investigators.

Facilitate recruiting expert peer reviewers.

Ensuring a formal, consistent review process for maintaining program integrity.

2.

3.

4.

Securing external research support services will serve to minimize AHBPCE administrative burden allowing us to shift attention to our other programmatic efforts.

The Contractor must provide the following tasks/deliverables with no exceptions:

Project management, including development of a project plan.

Setup of a shared web-based database with a tutorial for staff and safeguarding procedures.

Review of all Pilot Project Program proposals for annual announcement (up to 20 per year) Review of up to five (5) AHBPCE- VA affiliated internal scientific proposals for critique annually before grant submission.

Recruitment of expert peer reviewers with subject matter expertise in submissions.

While meeting the key requirements as stated in the Performance Work Statement (PWS).

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

The nature of this acquisition requires a Contractor who has all the key requirements as requested by the Program Office. The AHBPCE was officially recognized by Congress and the President in Public Law 1515-929. As a VA Center of Excellence, the main focus:

VHAPG Part 808.405-6 Limiting Sources Revision: 01 Effective Date: 09/01/2024

Clinical and translational research related to airborne hazards and burn pits.

Specialized evaluations and diagnostic approaches to unexplained shortness of breath and other respiratory conditions.

Detection of emerging patterns in health conditions using data from the Airborne Hazards and Open Burn Pit Registry.

Education that involves developing and disseminating best practices that can improve health outcomes for Veterans.

The Center of Excellence at AHBPCE and its colleagues routinely publish their research in peer-reviewed publications and present it at national and international scientific gatherings.

Keeping in mind in meeting the Program Office need. As indicated in the Market Research, there were no capable vendors that qualify to meet the required services as illustrated in the PWS except for one vendor whose technical capability has demonstrated they are actively engaged on the regular, ORAU’s team of researchers and information scientists provides a network of over 24,000 global subject matter experts enables them to find and recruit from any academic or professional discipline for peer reviews and program assessments.

If there are other vendors capable, we cannot make that determination since those vendors did not submit their expression of interest for this requirement. Only one vendor met suitability and it was evident that they are capable to meet the requirement.

Therefore, it is imperative that the Government award to a Contractor who is able to and who must meet all the key requirements as stated in the PWS without any deficiency to ensure there are no delay in fulfilling the agency’s requirements due to the contractor’s lack of capability or resources in meeting the requirements need. Further, to avoid duplication of efforts and cost to the government that is not expected to be recovered through competition.

FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

FAR 8.405-6(b): Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is:

These are “direct replacements” parts/components for existing equipment.

VHAPG Part 808.405-6 Limiting Sources Revision: 01 Effective Date: 09/01/2024

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing.

(5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination:

The Contracting Officer will determine fair and reasonableness of the proposed prices through historical data comparison of similar services rendered found on the Federal Procurement Database Search (FPDS) and the Independent Government Cost Estimate (IGCE), market research, and other available price analysis techniques in accordance with FAR 13.106-3(a)(2).

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

On January 10, 2025, the Contracting Officer conducted market research using Dynamic Small Business Search (DSBS) and Federal Procurement Database Search (FPDS).

Dynamic Small Business Search – DSBS

CONDUCT PEER REVIEW

The search with conduct peer review keywords found zero profiles within the search criteria.

TECHNICAL PEER REVIEW

The search for technical peer review found zero profiles within the search criteria.

PEER REVIEW PROCESS

The search with peer review process keywords found two profiles within the search criteria:

The Net.America Corporation and Zauron Labs, Inc. The keywords peer review process was filtered with NAICS 813920; this search found one profile within the search criteria: Zauron Labs Inc.

RESEARCH PEER REVIEW

The search with the keyword’s research peer review found zero profiles within the search criteria.

SCIENTIFIC PEER REVIEW

The search with the keywords scientific peer review found zero profiles within the search criteria.

MEDICAL PEER REVIEW

The search for the keywords medical peer review found two profiles within the search criteria:

ALPS Services, Inc. and FMAS Corporation. The search for the keywords medical peer review was filtered with NAICS 813920; this search found one profile within the search criteria: ALPS Services, Inc.

EXPERT EVALUATION

The search with the keywords expert evaluation found one profile within the search criteria:

Tax Gap Advisors. The keywords expert evaluation was filtered with NAICS 813920; this search found zero profiles within the search criteria.

VHAPG Part 808.405-6 Limiting Sources Revision: 01 Effective Date: 09/01/2024

EXPERT REVIEW

The search with keywords expert review found five profiles within the search criteria: User Insight, Inc., Howard S Shapiro, MD, Gibb & O’Leary Epidemiology Consulting, LLC, Richter Geology PLLC, and ESGPLUS, LLC. The keywords expert review was filtered with NAICS 813920;

this search found zero profiles within the search criteria.

SCHOLARLY REVIEW

The search with scholarly review keywords found zero profiles within the search criteria.

Federal Procurement Database Search - FPDS

CONDUCT PEER REVIEW

The search with the following keywords "conduct peer review" found 147 actions within the search criteria. The search with the keywords "conduct peer review" was filtered with PSC R410; this search found zero actions within the search criteria. The final search with the keywords "conduct peer review" was filtered with NAICS 813920; this search found 27 actions within the search criteria.

TECHNICAL PEER REVIEW

The search with the keywords technical peer review found 3,341 actions within the search criteria. The search with the keywords technical peer review was filtered with PSC R410; this search found 20 actions within the search criteria. The keywords technical peer review was filtered with NAICS 813920; this search found zero actions within the search criteria. The search with keywords technical peer review was filtered with NAICS 813920 and PSC R426; this search found zero actions within the search criteria.

PEER REVIEW PROCESS

The search with keywords peer review process; this search found 175 within the search criteria.

The keywords peer review process was filtered with PSC R410; this search found two actions with the search criteria. The keywords peer review process was filtered with NAICS 813920; this search found two actions within the search criteria. The final search with the keywords peer review process was filtered with 813920 and PSC R410; this search found zero profiles within the search criteria.

RESEARCH PEER REVIEW

The search with keywords research peer review; this search found 13,322 actions within the search criteria. The keywords research peer review was filtered with PSC R410; this search found 351 actions within the search criteria. The keywords research peer review was filtered with NAICS 813920; this search found 584 actions within the search criteria. The final search with keywords research peer review was filtered with 813920 and PSC R410; this search found 33 profiles within the search criteria.

SCIENTIFIC PEER REVIEW

The search with the keywords scientific peer review; this search found 2,462 within the search criteria. The keywords scientific peer review was filtered with PSC R410; this search found nine actions within the search criteria. The keywords scientific peer review was filtered with NAICS 813920; this search found zero actions within the search criteria. The final search with

VHAPG Part 808.405-6 Limiting Sources Revision: 01 Effective Date: 09/01/2024 keywords scientific peer review was filtered with 813920 and PSC R410; this search found zero profiles within the search criteria.

MEDICAL PEER REVIEW

The search with the keywords medical peer review; this search found 886 actions within the search criteria. The keywords medical peer review was filtered with PSC R410; this search found 53 actions within the search criteria. The keywords medical peer review was filtered with NAICS 813920; this search found 359 actions within the search criteria. The final search with keywords medical peer review was filtered with 813920 and PSC R410; this search found 25 profiles within the search criteria.

EXPERT EVALUATION

The search with keywords expert evaluation found 829 actions within the search criteria. The keywords expert evaluation was filtered with PSC R410; this search found two actions within the search criteria. The keywords expert evaluation was filtered with NAICS 813920; this search found zero profiles within the search criteria. The final search with keywords expert evaluation was filtered with 813920 and PSC R410; this search found zero actions within the search criteria.

EXPERT REVIEW

The search with keywords expert review found 3,817 actions within the search criteria. The keywords expert review was filtered with PSC R410; this search found 15 actions within the search criteria. The keywords expert review was filtered with NAICS 813920; this search found 21 actions within the search criteria. The final search with keywords expert review was filtered with 813920 and PSC R410; this search found two actions within the search criteria.

SCHOLARLY REVIEW

The search with the keywords scholarly review; this search found 27 actions within the search criteria. The keywords scholarly review was filtered with PSC R410; this search found zero within the search criteria. The keywords scholarly review was filtered with NAICS 813920; this search found zero actions within the search criteria. The final search with keywords scholarly review was filtered with 813920 and PSC R410; this search found zero actions within the search criteria.

(7) Any Other Facts Supporting the Justification:

The Program Officer requires that the vendor meets all the key requirements without any deficiencies in any of the key requirements to be considered.

i. Key Requirements:

1. Over 5 years of experience conducting scientific peer reviews and summarizing discussions.

A secure web-based platform for peer review, ensuring confidentiality of submissions and critiques.

Access to a diverse pool of over 250 doctorate-level expert reviewers for comprehensive assessments.

Timely management of the peer-review process and synthesis of results.

2.

3.

4.

VHAPG Part 808.405-6 Limiting Sources Revision: 01 Effective Date: 09/01/2024

ii. Preferred Attributes:

1. Previous experience working with federal agencies on managing peer reviews for research proposals.

Upon review of the technical capabilities provided and reviewing the websites of the expressions of interest, only one vendor met suitability and understood what is required to meet the need. Further, there weren’t sufficient evidence from the expressions of interest to support the required experience within scope of work of the requirement to consider competition.

Both vendors were reviewed.

Deltek, UEI: X33ZSBRJNNL9, currently has an active SAM.gov registration. Deltek's main NAICS is 513210 Software Publishers. UEI X33ZSBRJNNL9 was searched on SBA VETCERT, but no data was found. DSBS found no data entry for UEI X33ZSBRJNNL9, therefore, making Deltek a Large Business. Deltek’s website https://www.deltek.com/en/about was searched to review what services the vendor provides. In conclusion, the vendor’s vision is to power project success by providing industry-specific software and solutions that maximize performance at every stage of the project lifecycle, enabling project-based businesses to achieve their purpose and transform the world. On January 10, 2025, the Contracting Officer went on FPDS and searched UEI X33ZSBRJNNL9. This search found 712 actions within the search criteria. UEI X33ZSBRJNNL9 was filtered with NAICS 813920; this search found zero actions. UEI X33ZSBRJNNL9 was filtered with PSC R410; this search found zero actions.

Oak Ridge Associated Universities (ORAU) UEI: JW7MLW3RRK34, currently has an active SAM.gov registration. In accordance with SAM.gov reps and certs, ORAU's socio-economic is Large Business. The UEI JW7MLW3RRK34 was searched on SBA VETCERT, and data entry was not found. ORAU SAM.gov profile under reps and certs had no NAICS listed, and on DSBS JW7MLW3RRK34 was not found. Therefore, making ORAU a Large Business. ORAU website About ORAU | ORAU was searched to review what services the vendor provides. In conclusion, ORAU is a 501(c)(3) not-for-profit organization, that has partnered with government agencies, universities, and corporate entities to provide innovative scientific and technical solutions that advance national priorities in science, education, security, and health, leveraging expert teams and a consortium of over 150 colleges and universities to serve federal, state, local, and commercial customers. On January 10, 2025, the Contracting Officer went on FPDS and searched UEI JW7MLW3RRK34. This search found 712 actions within the search criteria. UEI JW7MLW3RRK34 was filtered with NAICS 813920; this search found two actions. UEI JW7MLW3RRK34 was filtered with PSC R410; this search found 42 actions.

Based on the correspondence received, two large businesses inquired about the RFI 36C24225Q0202. Based on the procurement history, this will be the first time this requirement will be procured for NCO 2. The Program Officer has conducted their research

VHAPG Part 808.405-6 Limiting Sources Revision: 01 Effective Date: 09/01/2024 http://www.deltek.com/en/about to find a vendor who best meets and fits suitability for this unique procurement need and determined that ORAU meets all of the program's need in minimizing biases and conflicts of interest in the internal review process, expanding the pool of eligible investigators, facilitating the recruitment of expert peer reviewers, and ensuring a formal, consistent review process to maintain program integrity. This procurement need is highly specialized, requiring unique expertise, proprietary technology, and continuity of work, making it in the best interest of the government to sole source in order to ensure timely, cost-effective, and high-quality delivery without the risk of delays or subpar performance from alternative vendors.

(8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made:

NCO 2 will continue to monitor the market to ensure that future sole sources are avoided.

Furthermore, a full market analysis will be conducted for the long term of the contract.

However, the potential actions that could be undertaken to remove the barriers to competition is to review and revise specifications stated in the PWS that is specific and particular in health research and studies that require peer review and merit. By conducting a comprehensive review of the procurement specifications will allow to identify and eliminate any unnecessary or overly restrictive requirements needed by the Program Office that may deter or limit potential vendors from participating. Currently, the caveat, is to not derail from the Program Office required need to meet all the key requirements just to consider competition.

(9) Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor’s supervisor, fund control point official, chief of service or someone with responsibility and accountability.)

MICHAEL

Digitally signed by MICHAEL FALVO Date: 2025.06.04 09:13:18

SIGNATURE DATE

Michael J. Falvo

NAME

Health Science Specialist

TITLE

WRIISC

SERVICE LINE/SECTION

East Orange VA Medical Center

FACILITY

VHAPG Part 808.405-6 Limiting Sources Revision: 01 Effective Date: 09/01/2024

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

CONTRACTING OFFICER/DESIGNEE’S SIGNATURE DATE

Contracting Officer Services Team 3 /NCO 2

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K):

I certify the justification meets requirements for other than full and open competition.

SIGNATURE DATE

NCO/PCO 02, Branch Chief

HIGHER LEVEL APPROVAL (Required for orders over $750,000):

c. VHA RPO HCA Review and Approval (over $750,000 to $75 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

NAME

VHA Head of Contracting Activity (HCA)

DATE

VHAPG Part 808.405-6 Limiting Sources Revision: 01 Effective Date: 09/01/2024

Joseph Cellino

Mariangie Rivera https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx