P03_36C24E-24-AP-0765_RandD_UW_long read_Redacted.pdf

OFOC R&D Academic Affiliate VAMC Wisconsin 36C24E-24-AP-0765 1

Justification and Approval (J&A)

For Other Than Full and Open Competition

Acquisition Plan Action ID: 36C24E-24-AP-0765

1. Contracting Activity:

Department of Veterans Affairs Regional Procurement Office (RPO) – East 323 North Shore Drive, Suite 500 Pittsburgh, PA 15212

Requesting Activity:

Department of Veterans Affairs VA Puget Sound Health Care System 1660 S Columbian Way Seattle, WA 98108

PR# 663-24-4-4160-0163

2. Nature and/or Description of the Action Being Processed:

The Puget Sound VA Medical Center Research and Development Section, Zabetian Laboratory intends to negotiate on a sole source basis a cost reimbursable non-commercial contract with its academic affiliate, University of Washington. This requirement will be to support research studies, specifically providing long-read sequencing data from selected participants to characterize regions of the genome that cannot be analyzed using short-read sequencing due to their complexity.

The contract is for a period of 17 September 2024 to 16 September 2029.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The University of Washington (VAPSHCS Academic Affiliate) Nanopore Sequencing Core provides the following DNA and RNA long-read sequencing services on the Oxford Nanopore Technologies (ONT) platform at cost to VAPSHCS: Sample Quality Control, Ligation Library Prep, Flow cell and time on the PromethION. The Nanopore Sequencing Core also will provide mentoring for the Zabetian Lab bioinformatician in processing and analysis of the long read sequenced data at no cost.

The anticipated value of this requirement is as shown below.

Period Dates

Year 1 9/17/24- 9/16/25 Year 2 9/17/25- 9/16/26 Year 3 9/17/26- 9/16/27 Year 4 9/17/27- 9/16/28 Year 5 9/17/28- 9/16/29 Total

OFOC R&D Academic Affiliate VAMC Wisconsin 36C24E-24-AP-0765 2

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

( ) (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 (x ) (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):

The University of Washington is an academic affiliate and collaborative research partner of VA Puget Sound Health Care System. 38 U.S.C 8153 authorizes sole source awards related to research with VA academic affiliates.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Due to the affiliate agreement with the proposed educational institution and the need for sustainable long term research support, solicitation among multiple sources is not available at this time. FAR 6.302(a)(2)(i) states, Full and open competition need not be provided when a statue expressly authorizes or requires that the acquisition be made through another agency or from a specified source. In accordance with 38 U.S.C. 8153 (a)(3)(A):

“If the healthcare resource required is a commercial service, the use of medical equipment or space, or research, and is to be acquired from an institution affiliated with the Department in accordance with section 7302 of this title, including medical practice groups and other entities associated with affiliated institutions, blood banks, organ banks, or research centers, the Secretary may make arrangements for acquisition of the resource without regard to any law or regulation (including any Executive order, circular, or other administrative policy that would otherwise require the use of competitive procedure for acquiring the resource)."

Should the requirements change, the potential to solicit to other vendors will be researched and considered.

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

Reasonable:

It is anticipated that cost to the government for this contract will be fair and reasonable as the University is a non-profit academic institution and academic affiliate of the VA Puget Sound Health Care System. Once the proposal is received, the proposed prices will be subject to price and costs analysis (as required) and negotiations may be conducted if the Contracting Officer determines this is necessary.

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. Due to the nature of the affiliate agreement with The University of Washington and the VA Puget Sound Health Care System, The University of Washington is the only source that can provide the required services.

OFOC R&D Academic Affiliate VAMC Wisconsin 36C24E-24-AP-0765 3

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

None

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None There are no other potential sources that can meet the specified requirements.

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:

The University of Washington, Inc is a longstanding affiliate to the VA Puget Sound Health Care System. Under the authority of 38 U.S.C. 8153 for research acquisitions, the VA Puget Sound Health Care System is entitled to use their affiliates for research purposes.

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.

Name: Susan Usher Date Title: Research and Development Lab Operations Manager VA Puget Sound Health Care System

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.

Renee Kale Date Contracting Officer Regional Procurement Office East

Name: Susan Ush

July 8, 2024

RENEE KALE

Digitally signed by RENEE KALE Date: 2024.07.16 06:32:44 -04'00'

OFOC R&D Academic Affiliate VAMC Wisconsin 36C24E-24-AP-0765 4

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K):

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

Seth Custer Date Division Chief Regional Procurement Office - East

7/15/2024

SETH

CUSTER

Digitally signed by SETH CUSTER Date: 2024.07.15 17:48:44 -04'00'