36C26325Q0263.docx

Attachment 9: Request for Sole Source Justification Format >SAT

GENERAL INFORMATION

SET-ASIDE

One Veterans Drive

Minneapolis MN

CONTACT INFORMATION

NETWORK 23 CONTRACTING OFFICE

Contract Officer 4801 Veterans Drive St. Cloud MN 56303

POINT OF CONTACT*

Contracting Officer Traci Johannes traci.johannes@va.gov 320-654-7635

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

DESCRIPTION

Presolicitation Notice Presolicitation Notice This Notice of Intent is provided to advise that the Government intends to award a sole source, Firm Fixed Price Base + 4 Option Year Purchase Order with only one source, Illumina, Inc. to provide Molecular Testing Reagents for the Minneapolis VA Health Care System.

This notice of intent to award a sole source contract is not a request for competitive proposals. However, in accordance with FAR 5.207 (c) (16) (ii), all responsible sources that feel they can meet the Government’s requirements detailed above may submit a capability statement which shall be considered by the agency. Responses to this notice shall contain sufficient information to establish the interested parties bona-fide capabilities for fulfilling the requirement and include: the Unique Entity Identification Number (UEI), and the Taxpayer Identification Number (TIN), along with documentation that the vendor is an authorized distributor/reseller. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information will be retained as Market Research.

All responses must be received by 16:30 PM CST on Friday, January 10th, 2025.

Responses shall be submitted electronically to Traci Johannes via email at traci.johannes@va.gov. Fax responses and Telephone inquiries will not be accepted.

Presolicitation Notice

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT)

1. Contracting Activity: NCO 23, Department of Veterans Affairs, VISN 23, Minneapolis, MN VA Medical Center

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

The Minneapolis VA Health Care System Molecular Laboratory is in need of a contract to provide highly specialized next generation sequencing reagents to be used on our owned Illumina Next Generation Sequencers (NGS), MiniSeq and Next Seq 550. These items are further specified in the schedule of items.

The MVAHCS currently owns two Illumina Next Generation Sequencers, the MiniSeq and the Next Seq 550 which support a VISN 23 Oncology Strategic Initiative. These analyzers perform massively parallel sequencing (also known as next generation sequencing) of DNA and RNA sequencing from biological samples to establish base sequences of nucleic acid molecules to identify correlates of disease from analyzed sequences. The MVAHCS uses these sequencers for simultaneous query of numerous genomic targets for detection of sequence alterations that are relevant in targeted clinical oncology, by using fresh and formalin fixed paraffin embedded tumor samples from cancer patients treated at the MVAHCS. Such analysis of multiple targets is becoming increasingly necessary in targeted oncology, and the MVAHCS needs to have this capability to meet emerging local service needs while reducing expensive send out testing.

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

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

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Illumina does not sell through a distributor and have provided sole source documentation.They are the sole manufacturer and distributor of their reagents.

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

Rachel Pike, COR contacted the vendor in summer 2024 to verify sourcing options. Only Illumina branded reagents are approved for use on our owned equipment. No other vendors reagents are approved for use. Illumina does not sell through a distributor and have provided sole source documentation. It was also verified that 3 of the 4 reagents are made in the US. 1 of the 4 reagents is made in Singapore, which is a Trade Agreement Act compliant country.

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

In general, it is fair and reasonable to expect laboratory supplies to have an annual price increase of approx. 2-5%. The quote appears to be 7%, which is high. Unfortunately, we don’t have any options to source reagents from a different brand or vendor as Illumina is the sole source of these reagents, and we have to use Illumina branded reagents on our owned Illumina equipment. They do not sell through a distributor, either.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Market research indicates that Illumina is the only vendor who can provide Illumina branded reagents to run on our owned Illumina equipment. Sole source documentation and the country of origin has been obtained. It is recommended to procure as a sole sourced, brand name only solicitation.

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

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

Illumina, Inc 5200 Illumina Way San Diego, CA 92122 800-809-4566

Adam Hauge Adam.hauge@illumina.com

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:

When it is time for laboratory to replace the existing owned equipment, we will evaluate all competition on the market at that time, and decide if equipment ownership/contracted reagents or leased equipment/contracted reagents best fits our needs at that time.

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.

VHAPG Part 806.3 OFOC Page 5 of 5 Revision: 02 Effective Date: 11/15/23 Acquisition ID#: 36C263-25-AP-0403