Genexus - Brand Name SSJ Over SAT 1 yr - Redacted.pdf

Effective Date: 02/01/2022 Page 1 of 3

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: Genexus Reagents and Supplies 36C241-24-AP-0414

1. Contracting Activity: Department of Veterans Affairs, VISN : Department of Veterans Affairs, Network/Program Contracting Office 01, in support of VISN 1 VA Health Care System Pathology and Laboratory Medicine Service.

2. Nature and/or Description of the Action Being Processed: This is a Brand Name Justification for the reagents and supplies for the Genexus instrumentation which performs specialized Next Generation Sequencing at VA Connecticut West Haven Molecular Diagnostics Laboratory. Testing includes but is not limited to SARS-CoV-2 gene sequencing and Pharmecogenomics. VISN 1 owns this equipment.

This is a requirement for Firm Fixed Price – 1 year. As requirements change, facilities within VISN 1 may be added or deleted by supplemental agreement of the Government and the Contractor.

Additional tests/reagents/instrumentation may be added to the BPA as new technology becomes available on the market.

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

Part Number Description

A40263 GXS TEMPL STRIPS 3-GX5 AND 4 C

A40271 GENEXUS SEQUENCING KIT COMBO

A40269 ION GX5 CHIP AND GXS COUPLER K

448852 96-WELL HARD SHELL PLATE CLEAR

AB0626X ADHESIVE FOIL SEALS MICROP

A40257 GENEXUS BARCODES 1-96 AS COMBO

A40258 GENEXUS BARCODES 1-32 AS KIT

A40259 GENEXUS BARCODES 33-64 AS KIT

A40260 GENEXUS BARCODES 65-96 AS KIT

A40266 GENEXUS PIPETTE TIPS 12 RACK/9

A51307 SARS COV2 INSIGHT PANEL GX 32

A47561 Ion AmpliSeq Pharmacoenomics Panel A40252 Ion Torrent Genexus Library Strips 1 ans 2-AS A40262 Ion Torrent Genexus Primer Pool Tubes Q33252 Qubit Flex Assay Tube Strips (125 Strips) Q33253 Qubit Flex Reservoirs (100 reservoirs) Q32851 Qubit dsDNA Quantitation, high sensitivity (100 assays) 95040450 KingFisher Plastics for 96 deep-well format (case of 50) 97002534 KingFisher 96 tip comb for deep-well magnets (case of 100) 97002540 KingFisher Plastics for 96 standard and PCR formats (case of 48)

Effective Date: 02/01/2022 Page 2 of 3

A36570 MagMAX DNA Multi-Sample Ultra 2.0 Kit (100 samples) A45540 Genexus Multi-Sample DNA Purification Kit (48 samples) 339650 Conical tubes, 15 ml 339652 Conical tubes, 50 ml 170368N Serological pipets, 25 ml 170369N Serological pipets, 50 ml J75793-AE Low TE Buffer A42363 Proteinase K 3449PK DNA LoBind tubes, 0.6 ml A40275 Conical bottles A40302 Filters A48310 MagMAX Viral Pathogen A57775 Dnase/Rnase free water

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

( X ) Only One Responsible Source and No Other Brand Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security

( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): VACT owns the Fisher Scientific Genexus Instrumentation; the reagent and supplies needed are highly specialized for the Genexus Next Generation Sequencing analyzer. Only the Genexus Brand reagents and consumables can be used as the level of quality required because the supplies or services are unique or highly specialized;

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: VACT already owns the 5 Genexus laboratory analyzers that cost over $600k each. These analyzers utilize propriatry reagents and cannot be provided by another source.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: It is determined that the anticipated cost will be fair and reasonable. This is based on a review of the IGCE, and historical data received from contract 36C24122A0017 which provides pricing information for the same testing reagent supplies being requested. After a thorough review

Effective Date: 02/01/2022 Page 3 of 3 of these documents one can concluded that the prices paid for these supplies in the past are relatively comparable to what we will pay for them today, taking into account variations in estimated quantities due to an increased demand for testing. The CO will also conduct an in-depth analysis of the market (using other various techniques) to ensure price reasonableness is achieved prior to contract award. In addtion, fair and reasonable pricing will be determined through compeititon.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: OEM Fisher Scientific provided a list of 2 (two) SDVOSB partners. An RFQ will be posted to see if there are any other companies available.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: VACT already owns the 5 Genexus laboratory analyzers. It would be the best value to continue utilizing this platform.

These analyzers utilize propriatry reagents and cannot be provided by another source.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Fisher Scientific Company L.L.C.; Veterans Healthcare Supply Solutions; Franklin Young

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: No actions are planned, VACT already owns the 5 Genexus laboratory analyzers that cost over $600k each. These analyzers utilize propriatry reagents and cannot be provided by another source.

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.

Jacqueline Hite Date Manager, Pathology & Lab VA Conn.

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.

Julie Lemire Date Contracting Officer, NOC1

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.

Sheryl Anthony Date Branch Chief, NCO1

JACQUELINE HITE

Digitally signed by JACQUELINE

HITE

Date: 2023.12.06 13:36:14 -05'00'

JULIE LEMIRE Digitally signed by JULIE LEMIRE Date: 2023.12.06 13:50:49 -05'00'