Sole Source Justification.pdf

VHAPM Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 3 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID:______36C250-21-AP-3794________________________________

1. Contracting Activity: Department of Veterans Affairs, VISN 10, Indianapolis Medical Center, Pathology/Moleculor Lab, requesting an Ion Sequencer testing equipment on 2237 #583-21-3-219- 0358.

2. Nature and/or Description of the Action Being Processed: VA has created a network of reference laboratories, called SEQFORCE, throughout the country to offer SARS-CoV-2 sequencing to all VA medical centers. The purpose of the network is to provide epidemiological data about the circulating SARS-CoV-2 strains, investigate outbreaks, determine if certain variants are more transmissible or likely to escape current vaccines, and identify new and emerging strains. The Indianapolis VA Molecular would like to acquire the specialized equipment to join the network of reference labs offering this service. Estimated cost is $339,901.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The ION Torrent Genexus system from Thermo Fisher best meets the needs/objectives. All other instruments are more expensive, more labor intensive, and less user friendly and do not include additional equipment necessary to accomplish future testing needs. This next-generation sequencing instrument supports an assay for sequencing the SARS-CoV-2 viral genome. By sequencing the viral genome of patients diagnosed with SARS-CoV-2 we will be able to investigate vaccine escape, re-infection, facility or regional outbreaks, and collect epidemiological data on circulating variant strains. This system is highly accurate, requires minimal hands-on time, and provides results for up to 100 samples per week, as required per the agreement to join SEQFORCE.

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 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

VHAPM Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

PM Part 813.5 SAP for Certain Commercial Items Page 2 of 3 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

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 OEM was contacted and confirmed that they are the only authorized distributor/supplier of this proprietary equipment/machine. They currently do not have any authorized SDVOSB or small business distributors.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Reviewed VetBiz and SBA with NAICS 334516 and keywords “Genexus Sequencer” with zero SDVOSB’s or Small Business found. In communication with the OEM, this newly created sequencer is only available through them at this time.

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

Reasonable: In review with other brand of sequencer, this brand was found to be at a fair and reasonable price and this system best meets the needs/objectives for path lab. All other instruments are more expensive, more labor intensive, and less user friendly and do not include additional equipment necessary to accomplish future testing needs.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Research FSS/GSA schedule holders and the open market. Reviewed list of sequencing assays for SARS-CoV-2, the virus known to cause COVID-19 2. Received various quotes for instruments and tests and reviewed user manuals and handbooks. Listened to webinar from Dr. J. Stacey Klutts at VA Central Iowa about two main platforms VA is using for sequencing for standardization.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Comparison of the Genexus with Illumina NextSeq was done with the technical brochures received. The findings are listed in the table below:

Feature Genexus NextSeq

# of Specimens per week

112 384

Run Turnaround Time 24-28 hours 48+ hours Minimal hands-on time Yes No-very manual, labor intensive setup Data Analysis Software Included

Yes No-Requires 3rd party for analysis(cloud based software application – unsecured network(s)).

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: A sources sought was posted on contract opportunities with no response received. Market research of FSS/GSA, open market found that the OEM is the only supplier of the requested sequencing equipment for the SARS-CoV-2 assays.