Sole Source Justification - Illumina Tecan Robots-iSCAN.pdf

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C256-22-AP-1808; 598-22-3-6701-0052

1. Contracting Activity: Department of Veterans Affairs, VISN 16 Central Arkansas Veterans

Healthcare System; 2237# 598-22-3-6701-0052

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

The purpose of this acquisition is to establish a new firm-fixed-price base (plus 4 option years) service agreement contract for maintenance on an existing iScan System in the Pharmacogenomics Analysis Laboratory, Central Arkansas Veterans Medical Center.

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

This action is to establish a new base contract with option years to be enacted on a service agreement for an Illumina iScan System with Autoloader 2 and its ancillary equipment, 2 Tecan Robots:

• Illumina Silver Service Contract for Tecan Roma – SN—808053768

• Illumina Silver Service Contract for Tecan Roma – SN—807005103

• Illumina Silver Service Contract for Autoloader 2 – SN—11139-858

• Illumina Silver Service Contract for iSCAN – SN—N0255

Our previous contract, 36C25618C0101, will expire in April 2022

Brief Description of Service* Period of

Performance

$ Per Period Estimated Amount

No. of Months or Years

By Month or Year

1 year Preventative Maintenance Service Agreement:

iScan, Autoloader 2, Tecan Robot 1 & 2 1 year $103,562.05 $103,562.05

Starting: April 24, 2022 Ending: April 23, 2023 1 year Preventative Maintenance Service Agreement:

iScan, Autoloader 2, Tecan Robot 1 & 2 1 year $107,704.53 $107,704.53

Starting: April 24, 2023 Ending: April 23, 2024 1 year Preventative Maintenance Service Agreement:

iScan, Autoloader 2, Tecan Robot 1 & 2 1 year $112,012.72 $112,012.72

Starting: April 24, 2024 Ending: April 23, 2025 1 year Preventative Maintenance Service Agreement:

iScan, Autoloader 2, Tecan Robot 1 & 2 1 year $116,493.22 $116,493.22

Starting: April 24, 2025 Ending: April 23, 2026 1 year Preventative Maintenance Service Agreement:

iScan, Autoloader 2, Tecan Robot 1 & 2 1 year $121,152.96 $121,152.96

Starting: April 24, 2026 Ending: April 23, 2027 SUBTOTAL (Services)

TOTAL IGCE $560,925.48

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 13.501.

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

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

There is only one responsible source for the service agreement on a highly-specialized microarray system and its ancillary equipment. This microarray system is a major system that produced more than 6 billion results in FY21 and is scheduled for use with projects into FY25. These projects are critical to genomic and pharmacogenetic projects for the Cooperative Studies Program (Washington, D.C.), Durham VAMC, Boston, VAMC, Seattle VAMC, MD Anderson and Mayo Clinic. Reasons why the equipment is specialized and requires Illumina engineers to maintain include the following:

1. Tecan Roma is a liquid-handling robot equipped with robotic arm capabilities that is barcode reader-ready for LIMS sample tracking. It is used by the Pharmacogenomics Analysis Laboratory (PAL) for faster genomic analysis. The Tecan Roma provides assay automation for GoldenGate, Infinium, and DASL Assays while streamlining workflow and reducing errors. The robot is a Tecan Freedom EVO 150 with a RoMa, custom barcode reader for scanning Beadchips, a PosID system for scanning reagents, and has a PC workstation.

2. Autoloader 2 is a device that automatically loads and unloads BeadChip carriers into an iSCAN.

This allows for handsfree operation and enables the user to walk away during scanning or leave to run unattended overnight. It is compatible for use in an iSCAN with Illumina BeadChips only.

This device has been precisely aligned to enable automated scanning. Positional changes will require a Field Service Engineer visit to realign the integrated system.

3. iSCAN is a cutting-edge array scanner using high performance lasers, optics and detection systems to offer sub-micron resolution and unmatched throughput rates. This system can be used in conjunction with the Tecan Roma and Autoloader 2 by using Illumina LIMS (laboratory information management software), which also provides downstream analysis of exported data. This unit may not be serviced by the user, but only by a qualified Illumina Field Service Engineer.

4. The Illumina Tecan Roma Robot interfaces with the PAL Laboratory Information Management system (LIMS) and has unique software that is compatible on several Illumina instruments located in PAL. Service for the Tecan Roma must be compatible in form and function with the service provided to all Illumina instruments that are operational in PAL. Only Illumina service engineers have access to software application updates for the Tecan Roma. Only Illumina service engineers have quality control specifications for the Tecan roma and the tools/expertise to correct any quality control deficiencies.

Accordingly, Illumina, Inc. is the only firm capable of providing the supplies and services described in Section III above without the Veteran’s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition and unacceptable delays in fulfilling its requirements.

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

The following techniques were used to solicit several potential sources:

Database Queries GSA Advantage Searches Discussions with Biotech Companies Review of Product Literature

The following questions were used to screen potential sources:

Q1 What type of training is offered to your service engineer on repairing the IScan?

Q2 How much experience do your service engineers have on IScan repairs?

Q3 Does your company keep stock of all replacement parts necessary to repair the IScan?

Q4 Does your company provide technical support by phone and email for the IScan?

Q5 What type of phone response and on-site visit response does your company offer?

Q6 Do the engineers provide electronic reports of all service visits? Are repairs documented and parts traceable?

Q7 What different types of service agreements are offered and what costs are involved?

Based upon the answers to these questions, specifically #3, it was quickly determined that Illumina, Inc. is the only responsible source for repairs to the iScan System and Tecan Robots. They have proprietary hardware & software, do not authorize 3rd parties to work on their equipment without voiding the warranty, do not train 3rd party biomedical engineers to repair their equipment, and do not sell parts to distributors or 3rd parties.

Additionally, a Notice of Intent to Sole Source was posted to SAM.gov inviting interested parties to respond with their capability to perform required services. Only one source responded, The Remi Group. However, they were unable to provide a letter from the OEM or an intermediary distributor authorized by the OEM stating they are an authorized dealer, authorized distributor or authorized reseller as will be required by VAAR 852.212-72(c).

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Price fair and reasonableness will be determined by comparison to the Independent Government Cost Estimate (IGCE) and past contract pricing which was previously determined fair and reasonable.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted:

After initial consultations with Illumina corporate office, it was verified that Illumina does not authorize any third-party vendors or allow any engineers other than their trained Field Service Engineers to repair or perform preventative maintenance on Illumina equipment. Verification of this claim was made by conducting market research to find veteran-owned business who offer repair services on Illumina equipment; none were found.

Please see “Atch 2 Market Research Over 250k Illumina iScan System.docx” for additional details.

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

Illumina is the only manufacturer of this equipment, it is necessary to have them complete any repairs and maintenance on these machines. The company owns all of the patents associated with the machine. All hardware and software within the machine is proprietary.

Illumina has not authorized any third-party service provider to perform maintenance and repair on AB instruments. Lapse of coverage for service agreements on instruments within the Pharmacogenomics Analysis Laboratory can result in project delays. Since we serve as a core laboratory for the Cooperative Studies Program (ORD) and as a national genomics laboratory for all VA investigators, instrument down-time can be detrimental to many funded projects.

Without a service agreement, repairs to existing equipment by ABI Service engineers would be prohibitive. Life Technologies charges a minimum of $350 per hour with a 2 hour minimum plus travel charges. If replacement parts are needed, such as electronic boards, the costs can exceed several thousand dollars quickly.

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

Name of Proposed Contractor: Illumina, Inc. The Remi Group Street Address: 5200 Illumina Way 6325 Ardrey Kell Rd., Ste. 200 City, State, Zip: San Diego, CA 92122-4616 Charlotte, NC 28277 Phone: 1-800-809-456 704-602-0844

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:

There are no known actions, planned or available, to remove or overcome any barriers to competition due to the proprietary nature of the software, hardware, engineering training, and parts inventory needed to repair these instruments.

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.

_____________________________ _3/9/2022_________________ Name: Dr. Richard Owen Date Title: ACOS of Research Facility: CAVHS

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.

James Hunt Date Contracting Officer

NCO 16

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.

Joseph L. Warren Date Chief, Procurement & Contracting Services Team D – Div I

NCO 16