P03 JandA 36C244-23-AP-1500_signed BC_Redacted.pdf

36C244-23-AP-1500 | Delivery, Installation, and Training of Illumina NG 550 DX Sequencing System | VA Pittsburgh Healthcare System | University Drive Campus

Request for Sole Source Justification >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 1 of 5

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN

COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C244-23-AP-1500

1. Contracting Activity:

Department of Veterans Affairs Network Contracting Office 4 1010 Delafield Road Pittsburgh, PA 15215-1802

Delivery of Illumina Next Generation 550 DX Sequencing System, Associated Equipment, Training, and Service Contract at VA Pittsburgh Healthcare System (VAPHS), University Drive Campus, University Drive C, Pittsburgh, PA 15240-1003. Purchase Request: 646-23-1-233-0129

2. Nature and/or Description of the Action Being Processed: The Medicine Service Line (MSL) requires a new Illumina Next Gen Sequencing system to establish a genetic sequencing laboratory.

This type of equipment has not been purchased previously. This is a brand name only request. The analyzer will be used in conjunction with the epMotion® 5075tc NGS solution w/ CleanCap to identify human pathogens via genetic sequencing.

VAPHS MSL requires this genetic sequencing system for the University Drive Campus. This analyzer will be used to sequence the genetic information of unknown pathogens for identification. At present, VAPHS does not have the capability to conduct onsite testing, this system will fill this testing gap.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: VAPHS MSL seeks to sole source this requirement. The NextSeq 550Dx is a WxDxH: 54x69x58 cm benchtop analyzer with Windows 10 operating system. The power supply is 100–120 VAC 15 A, 220–240 VAC 10 A. The following items are require.

Total Estimated Cost for this requirement is

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:

Effective Date: 02/01/2022 Page 2 of 5

( 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): NCO4 correspondence with the OEM ( ) indicates that beyond maintaining General Service Administration and Defense Logistic Agency Electronic Catalog Accounts with one authorized distributor ( , does not maintain distributors in the United States (03-01-2023).

The brand name only requirement is that VAPHS end users are familiar with the NextSeq and have performed testing using this analyzer at other facilities. As other local experts will be assisting with the validation and testing, it is in our best interest to have an analyzer that they are already familiar with in order to reduce the amount of time and funding needed for additional training. At present VAPHS is the lead for five investigative projects (listed below) that require this system. Acquiring the onsite capability of the Illumina Next Generation Sequencing allows for the seamless and efficient integration of not only these projects and further allows VAPHS to leverage the genetic sequencing capability currently outsourced to other facilities.

Since this style of testing is one of the most complicated in the laboratory and it is critical that the end users are comfortable with the analyzers that they are using. Genetic testing has some of the highest standards for quality control and precision requirements. This brand of equipment will ensure that these requirements are met.

VAPHS in their vetted Veterans Integrated System Network 4 request for high cost high technical equipment (VISN4) reports the following:

“This analyzer provides efficient and highly accurate DNA and RNA sequencing. Healthcare associated infections (HAIs), COVID-19, influenza and other respiratory viruses, Legionellosis and other infectious diseases are serious challenges in VA healthcare systems, causing significant morbidity and mortality. HAIs can be caused by the transmission of bacteria (including MRSA, other highly antibiotic resistant pathogens and Clostridium difficile), viruses, and fungi (including Candida auris and other antifungal resistant fungi). It is essential that infection prevention (IP) teams understand how these pathogens are transmitted to effectively take steps to prevent outbreaks and HAIs, and to keep hospital water and physical environments safe. Whole genome sequencing (WGS) of microbes is poised to revolutionize IP practice, allowing healthcare systems to rapidly identify case clusters, outbreaks, and microbial transmission between patients and within the environment. As shown by the COVID-19 pandemic, WGS is also essential to understand the epidemiology and transmission of viruses and bacteria that are acquired outside of the hospital. Ability to perform WGS on-site allows healthcare systems to respond rapidly and proactively to infectious diseases problems, as shown by early remediations of outbreaks due to gastroscopes (1), interventional radiology (2), and hospital-acquired Legionella sp. (3). In additional to ad hoc WGS to work up possible outbreaks, it is now possible to sequence all microbiology specimens and use bioinformatics to monitor for clusters in real time. These powerful approaches are significantly more effective at identifying clusters than traditional IP epidemiologic methods alone (4). In a multi-year analysis, researchers

Effective Date: 02/01/2022 Page 3 of 5 recently showed that a prospective WGS surveillance program was cost effective, identified outbreaks earlier, and allowed IP to intervene sooner and prevent further transmission (5). Real time, proactive WGS is estimated to prevent 50% of transmission events and HAIs.

This equipment will be used to establish an ad hoc and prospective WGS surveillance program at VAPHS to monitor for outbreaks of HAIs, reduce transmission of bacteria, fungi and viruses, track patterns and types of viral and other infections contracted both inside and outside the hospital, and understand sources of Legionella and other microbes within water systems and hospital environments.

On-site WGS also has cutting-edge research applications, which will allow VAPHS and the IP program to develop investigative projects and grants in the future.

Sundermann AJ, Chen J, Miller JK, Saul MI, et al. Outbreak of Pseudomonas aeruginosa Infections from a Contaminated Gastroscope Detected by Whole Genome Sequencing Surveillance. Clin Infect Dis. 2021 Aug 2;73(3):e638-e642.

Sundermann AJ, Babiker A, Marsh JW, et al. Outbreak of Vancomycin-resistant Enterococcus faecium in Interventional Radiology: Detection Through Whole-genome Sequencing-based Surveillance. Clin Infect Dis. 2020 May 23;70(11):2336-2343.

Rosendahl Madsen AM, Holm A, Jensen TG, et al. Whole-genome sequencing for identification of the source in hospital-acquired Legionnaires' disease. J Hosp Infect. 2017 Aug;96(4):392-395.

Sundermann AJ, Chen J, Kumar P, et al. Whole Genome Sequencing Surveillance and Machine Learning of the Electronic Health Record for Enhanced Healthcare Outbreak Detection. Clin Infect Dis. 2021 Nov 17:ciab946.

Kumar P, Sundermann AJ, Martin EM, et al. Method for Economic Evaluation of Bacterial Whole Genome Sequencing Surveillance Compared to Standard of Care in Detecting Hospital Outbreaks. Clin Infect Dis. 2021 Jul 1;73(1):e9-e18.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: NCO4 contacted the OEM to determine the firm’s business strategy for distribution. Due diligence was paid to the OEM’s distributor, and NCO4 reviewed both the Vendor’s Defense Logistics Agency’s Electronic Catalog and General Service Administration’s Federal Supply Schedule. Vendor’s pricing for both venues was greater that of OEM’s pricing. NCO4 posted an Intent to Sole Source to the OEM on SAM CO to further confirm marketplace validation of this requirement. No Vendors responded.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: NCO4 will leverage the following sources, beyond just vendor competition for determining price reasonableness. Federal Procurement Data System (FPDS), VA Supply Chain Master Catalog (SCMC), and Defense Logistics Agency (DLA) Electronic Catalog (ECAT) are the Government databases that NCO4 will use in the determination of price reasonableness.

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

Market Research Was Not Conducted: NCO4 conducted he following Market Research for this requirement.

System for Award Management (SAM) Contract Opportunities. NCO4 released an Intent to Sole Source on System for Award Management (SAM) Contract Opportunities (CO) on 03-24-2023 with

Effective Date: 02/01/2022 Page 4 of 5 responses due 04-03-2023. No Vendors responded in accordance with instructions provided in the Notice.

Small Business Administration (SBA) Dynamic Small Business Search (DSBS) Tool. NCO4 searched the DSBS database using NAICS Code 339113 and search terms “Illumina” and “NextEQ” (04-14-2023). The “Illumina” search yielded two results based on similarity to the search word and have no bearing concerning this requirement. The “NextSeq” search bore no results.

VHA Procurement Guide (VHAPG) Nonmanufacturer Rule (NMR) Decision Tree. NCO4 confirmed via the VHAPG Nonmanufacturer Rule (NMR) Decision Tree, that NAICS Code 339113 has no Small Business Administration (SBA) Class Waiver. This condition precludes setting this acquisition aside for SD/VOSB Vendors. NCO4’s correspondence with OEM, Senior Executive Account Manager, indicates that the OEM sells the equipment to the US Government on the Open Market. They maintain an SD/VOSB Vendor for sales on GSA and ECAT Market Places. NCO4 has confirmed that Illumina’s authorized distributor, is SD/VOSB via the SBA’s Veteran Small Business Certification (VetCert) database (04-12-2023).

VA National Contracts. NCO4 searched the National Acquisition Center (NAC) Contract Catalog Search Tool (CCST) using the term “NextSeq” (04-14-2023). Search yielded one result. This was the WATSON GENOM CORE 1/Next Generation Sequencing, Illumina Sequencing. This item is a test kit that allows for the duty station to send back for results.

NCO4 searched the Strategic Acquisition Center (SAC) SharePoint site using the search term “NextSeq”. The search yielded no results.

Non-VA Contracts. NCO4 reviewed both Defense Logistics Agency’s Electronic Catalog (ECAT) and General Service Administration’s (GSA) Advantage search engine. CO was able to determine that while the SD/VOSB Vendor GeoMed, LLC maintains both items pricing is higher that the quote that the OEM provided. ECAT Difference was and the GSA Difference was

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Gray Market regulations currently preclude using any vendor that does not have OEM authorization for warranty, maintenance, and servicing of this brand name only suite of equipment. The duty station’s requirement requires Stryker suite of equipment and inherent protections provided by authorized distributors and solicitation and contract will include VAAR 852.212-71.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: NCO4 correspondence with the OEM indicates that beyond maintaining General Service Administration and Defense Logistic Agency Electronic Catalog Accounts with one authorized distributor , does not maintain distributors in the United States (03-01-2023).

NCO4 further posted an Intent to Sole Source Notice on SAM CO. No Vendors responded.

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:

Technological advances in the genetic sequencing market place may change the need for a brand name only procurement. Recommend increased Governmental Category Management type contracts to leverage economy of scale and make a buy like this a Delivery Order versus Open Market procurement.

Effective Date: 02/01/2022 Page 5 of 5

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:

Laboratory Manager Pittsburgh VA Healthcare System University Drive Pittsburgh, PA 15240 Government Technical Point of Contact (GTPOC)

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.

Mark E. Murray Contracting Officer Commodities 2

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.

Karen Callahan Branch Chief Commodities 2