P03 Sole Sources Justification_Redacted.pdf

OFOC SOP Revision 10 Page 1 of 4 Original Date: 03/22/11 Revision 10 Date: 09/10/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 236C241-20-AP-2468

1. Contracting Activity: Department of Veterans Affairs, VISN 01, VA Connecticut Healthcare System, 950 Campbell Avenue, West Haven CT 06516

PR-ICAP: 689-21-1-7455-0031

2. Nature and/or Description of the Action Being Processed: This is a follow-on to an expiring Indefinite Delivery Contract (IDC) that will expire 9/30/2020. The following reagents/supplies are required to continue performing in-house CYPC19 and add HCVg testing at the VA Connecticut Molecular Diagnostics Laboratory. The eSensor 2C19 assay provides CYP2C19 genotyping results which allow clinicians to predict the optimal therapeutic dosage of Plavix and other drugs which can reduce the likelihood of heart attack and stroke caused by under-dosing. In the case of HCVg Direct Genotyping, results also drive clinical treatment and therapy decisions. The estimated value of the proposed action for 1 year is $56,971.20 / 5-years $284,856.00.

Product Description Part Number Est. Annual Qty.

eSensor 2C19 Test Kits MT06002 2 HCVg Direct MT002002 20

3. Description of Supplies/Services Required to Meet the Agency’s Needs: VHA Handbook 1106.01 requires the Laboratory use FDA approved tests whenever possible. This testing platform is FDA approved and currently in use at the Molecular Diagnostics Laboratory. These reagents are instrument-specific; therefore, no other reagents can be used on the eSensor. Additionally, the GenMark CYP2C19 HCV genotype assays are validated on the eSensor platform which is owned by the VA. Assays from another vendor’s are not designed for and cannot be run on the GenMark platform. Substitutions are not allowed. HCV Genotype assay – VA Connecticut Molecular Diagnostics Laboratory has made the decision to change HCV Genotype testing platforms. By switching to this platform for HCV genotype, we can eliminate a whole other instrument (Siemens), resulting in a cost savings on service contracts. The other additional savings comes from the former platform changing to swapping out instruments for preventive maintenance instead of on-site maintenance, which forces the laboratory to perform a costly and time-consuming validation once a year. Reagent cost for GenMark vs. Siemens is slightly reduced ($46,084.50 per year vs. GenMark quote $45,600 per year). The GenMark instrument requires less tech time to operate, zero tech and pathologist time to interpret the results due to the instrument reporting the results. GenMark eSensor is used by more laboratories overall and within the VA system. Any other platform would require a major capital purchase and would require increased tech time.

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

OFOC SOP Revision 10 Page 2 of 4

Revision 10 Date: 09/10/2020

( X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Per 6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirement. As indicated above, the products can only be provided through the manufacturer. They do not have any authorized small business distributors for eSensor 2C19 Test Kits and HCVg Direct. The reagents and kits are specific to equipment provided by GenMark Diagnostics testing; eSensor 2C19 Test is designed for the multiplex detection and genotyping of the *2, *3, *4, *5, *6, *7, *8, *9, *10, *13 and *17 alleles of the cytochromes P450 (CYP450) 2C19 gene locus, and HCVg testing is designed for typing and subtyping Hepatitis C virus (HCV) 1a, 1b, 2, 2a/c, 2b, 3, 4, 5, and 6.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Requests for information were posted and sent out to all prospective contractors. GenMark Diagnostics is the only contractor providing the reagents pursuant to the equipment in use. The equipment was purchased in 2015 with the reagents to be used at the time. Although, one of the reagents for testing has changed. It is still pertinent in use for the equipment in place. Switching to a new system if available would involve a large investment in time, money, and training. Finally, it would cause a disruption in patient care, and become more costly to source out. in sourcing out. The only authorized distributor for GenMark is Government Scientific Sources Incorporated. Unfortunately, they are not authorized to sell the HCVg Direct.

Name of Offeror Name and Address of Building GenMark Diagnostics Inc. 5964 La Place Court, Carlsbad, CA 92008 Government Scientific Sources Inc.

12351 Sunrise Valley Drive, Reston VA 20191

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: There were no other contractors found to offer the specific type of testing. GenMark responded to Request for Information. Their pricing was consistent with the services revision of the estimated cost for 1 year is $56,971.20 / 5-years $284,856.00.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: The following sites were searched; Federal Procurement Data System (FPDS), General Services Administration (GSA), North American Industry Classification System (NAICS), Vendor Information Page (VIP), Sources Sought Notice – Federal Opportunities (FBO). Reached out to manufacturer/distributors for additional information.

Searched FPDS for eSensor Reagents, GenMark Diagnostics Inc. was the only provider listed as the manufacturer/distributor for that product. Search GSA Advantage for product and company, OFOC SOP Revision 10 Page 3 of 4

Revision 10 Date: 09/10/2020

GenMark equipment was listed, but not the reagents/kits under GenMark. In searching GSA eBuy, GenMark was listed, but only as a source for distributors. GSA lists Government Scientific Source Inc.

(Small Business) as the distributor for the reagents. 325413 is listed on the NAICS as In-Vitro Diagnostic Substance Manufacturing. Reagents are only needed, GenMark equipment currently in place. VIP searched found 6 contractors under NAICS/Key Word. An RFI was sent to all contractors listed. Sources Sought Notice was posted on FBO. Calls were made to GenMark Diagnostic Inc.

(Small Business) and Government Scientific Source Inc. (Small Business).

VIP RFI#AP2468 was sent to all vendors listed on the VIP under NAICS 325413. No responses were received.

GSA e-mail was sent to GenMark Diagnostics ( , Senior Molecular Account Executive for New England, ). An informal quote was provided by GenMark for eSensor CYP2C19 Kit and HCVg Direct products. He indicated that the products are offered direct through GenMark open market, and Government Scientific Sources Inc. off their GSA Schedules (GS-07F-5934R/GS-07F- 0065Y).

Sources Sought Notice 36C24120Q0484 was posted on FBO. Responses were received from GSS and GenMark. Both companies were able to provide the products that were listed prior to the change by the service. Government Scientific Source Inc. was an authorized distributor for eSensor CYP2C19 Kits (RUO) and eSensor Warfarin Sensitivity SC Kits (IVD), but not the HCVg Direct kits. Per the service, Warfarin Kits were no longer needed. The new kits needed are; HCVg Direct that can only be provided through GenMark Diagnostic Inc. Revisions to IGCE, and requirement were made by the service that included HCVg Direct products. Due to the change, the 5-year total cost was over the Simplified Acquisition Threshold (SAT). The service is also moving from an IDC to a BPA for the 5-years. The products will be ordered as needed by the VA Connecticut Healthcare System.

Based on the above information, only one company can provide the products as a follow-on to what is currently in place.

• GenMark Diagnostics (Small Business/Open Market)

Based on the above information, there is only one company that can provide the above products as a continuation to what is currently used and in place. Will submit 2268 request to purchase direct from GenMark Diagnostics (Small Business) with a Source Justification

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Contacted the following individuals; , Senior Molecular Account Executive – New England, GenMark Diagnostics, they can provide the products open market. , Government Scientific Source Incorporated (Small Business), Customer Service Supervisor (8/28/20). I was informed that “ unfortunately I will have to submit a no bid on this as we do not have access to the requested items.” Additional points considered, the equipment is owned and in place, cost and disruption of changing contractors/equipment at this junction, re-validation of equipment and reagents would take several weeks to months causing a delay in patient care, and staff training.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: GenMark Diagnostic is interested in continuing to provide the products currently for testing, and the new product that’s