P03 SSJ - NDRI follow on signed Signed DR.pdf

Attachment 7: Request for Sole Source Justification Format >SAT

VHAPG Part 806.3 OFOC Page 1 of 3 Revision: 01 Effective Date: 04/01/23

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C241-23-AP-4230

1. Contracting Activity: Department of Veterans Affairs, VISN 1, NCO 1 on behalf of VA Boston

Healthcare System, MA. The purchase request number is 523-23-4-1865-0143.

2. Nature and/or Description of the Action Being Processed: The PTSD Brain Bank is seeking a renewed sole source contract with the National Disease Research Interchange (NDRI) for nationwide collection, transport, and delivery of postmortem brain tissue per the Scope of Work. This is a follow on of an existing contract, 36C24118D0078, with NDRI for pathology and transport services that ended 7/14/2023. NDRI will provide the PTSD Brain Bank with high quality tissue obtained through a nationwide network of recovery specialists. NDRI will coordinate transport of this tissue to the VABBB facilities (in either Boston or Tucson). The requirement is approximately $431,285.29.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The VA Brain Bank is a brain tissue collection biorepository. Donors to the VA Biorepository Brain Bank (VA BBB) are located nationwide, and therefore it is necessary for us to work with a vendor that has recovery specialists located in all 50 states. The quality and experience of the recovery specialists that NDRI provides is top tier, which is necessary given the level of precision and specificity required. This is for CNS recovery. NDRI will provide pathology and transport services for up to 60 donors per year. This is anticipated to be a one-year requirement.

4. Statutory Authority Permitting Other than Full and Open Competition:

( x) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4

( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition

Requires the Use of the Authority Cited Above (applicability of authority): This is a follow- on contract for a highly specialized service. Failure to implement a new contract with NDRI will result in unacceptable delays in pathology and transport services. Given the time sensitive nature of brain donation, any delay in recovery of brain tissue and subsequent transport to the lab will severely deteriorate tissue quality, rendering the brain tissue unusable in research. NDRI is the only vendor capable of providing pathology and transport services of this caliber to the VABBB.

NDRI has a unique private donor program, which has the necessary established expertise and experience to provide comprehensive project management and pathology services to the VABBB for the recovery of brain and spinal cord tissues from enrolled donors. The Pilot Study chose NDRI based on the organization’s proven experience and established systems for recovering tissues from deceased donors nationwide. NDRI maintains a database of consented patients and next-of-kin details to facilitate tissue recovery postmortem. At or just prior to the time of death, NDRI is notified and

VHAPG Part 806.3 OFOC Page 2 of 3 Revision: 01 Effective Date: 04/01/23 makes arrangements with their network of contracted recovery personnel (pathologists) to recover brains and associated tissues and ship them directly to the designated VA brain banks. The costs for establishing the network of pathologists, maintaining a donor database, gathering, and maintaining knowledge of approved tissue transport services has already been covered. Any new vendor would have to expend substantial resources to acquire this same knowledge, experience, and resources; those costs would then have to be passed on to VA thus preventing any possible savings that could be gained through competition.

Continuity of services is required for these mission-critical and highly specialized services. Opening this requirement up to another vendor presents a high risk of losing contact with the current cadre as well as losing the program’s momentum that has been gained over the last 10 years. The risks associated do not support opening this requirement to competition; they are simply too great. There is no advantage to be gained through competition and the risks of possible loss of participants and the program’s gains must be mitigated by awarding the next contract on a non-competitive basis. NDRI is the only organization which has the necessary demonstrated leadership, resources, and core competencies to provide continuity in the collection of high-quality brain and spinal cord specimens from donors enrolled in the VABBB donor registry. Previous market research conducted comparing prices of similar vendors for similar services was taken into consideration.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Requirements for research endeavors are very specific in nature and frequently there is only one responsible source. There is very little the agency can do to open up this highly specialized requirement to competition. NDRI provides the best service at the best price to the VABBB. Other vendors considered were the International Funeral Service of New York, Southwest Cargo, and Casper Funeral Services. NDRI is unique in its consolidation of pathology and transport services, making it the quickest way to coordinate a postmortem tissue donation. Time is of the utmost importance in these tissue donations. Furthermore, the existing relationship between the NDRI recovery specialists and the VABBB ensures quality recovery by experienced specialists.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: Anticipated recovery costs estimates have been provided by the vendor based on 10 years of experience with the VABBB.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was conducted for this follow-on contract.

The original contract 36C24118D0078 was procured as a sole source to NDRI. A VIP search revealed no potential SDVOSB/VOSB vendors. The rule of two could not be met for SDVOSB/VOSB vendors. An SBA DSBS search using NAICS, and keywords brain transport revealed no potential SB vendors. The rule of two could not be met for SB vendors. Only one vendor can meet this requirement, large business NDRI.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Pathology and transport services used to be coordinated by VABBB members themselves. However, due to growth and expansion of recruitment into the VABBB since its inception, it has been necessary to have a 24/7 team dedicated to the coordination of these recoveries.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: N/A

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: A follow-on action is likely planned, unless another vendor with the capability to perform the same caliber of combined project management, pathology, and transport services is available. Given the unique nature of this highly specialized requirement and the collaborative nature of the research

VHAPG Part 806.3 OFOC Page 3 of 3 Revision: 01 Effective Date: 04/01/23 work being conducted services must continue to be met through the sole source provisions of FAR 6.302-1.

12. 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 and belief.

Olivia Dejoie Date Contracting Officer’s Representative

NCO 1

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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

Tara Dossiema Date Contracting Officer

NCO 1

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Deborah Reardon Date Commercial Team 1 Branch Chief

NCO 1

OLIVIA DEJOIE

Digitally signed by OLIVIA

DEJOIE

Date: 2023.09.12 10:59:10 -04'00'

9/12/2023

9/12/2023

9/12/2023