J A Sole Source NCO1 AP 36C241-23-AP-0414 SIGNE.pdf

Effective Date: 02/01/2022 Page 1 of 4

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN

COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C241-23-AP-0414

1. Contracting Activity:

The contracting activity is VHA Regional Procurement Office East, Network Contracting Office 1

New England which is supporting the VA Million Veteran Program (MVP). The MVP is located at the VA Boston Healthcare System, 150 S. Huntington Avenue, Jamaica Plain, MA 02130.

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

The contracting officer is considering a five-year single-award Indefinite Delivery Indefinite Quantity

(IDIQ) contract under the simplified and streamlined procedures of FAR 13.5. The contractor under consideration is Tasso, Inc. (Tasso) as sole source awardee. This acquisition procures customized blood sample collection kits and the secure distribution and routing of the kits for analysis. Also included are necessary related data transfers to and from MVP and the contractor for the distribution and tracking of kits to veterans. The contractor shall furnish all personnel, equipment, tools, supervision, items, and services needed to carry out task orders issued pursuant to the statement of work and terms and conditions of prospective IDIQ.

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

This is a procurement for distribution and tracking services and for a concomitant contractor micro-sampling device, the Tasso+ in kit form. Tasso is the sole manufacturer of Tasso+ a Class II 510k device approved for use by the FDA August 12, 2022 (#K221131). The Tasso+ is a single-use blood lancing device intended for obtaining microliter capillary whole blood samples. Tasso will distribute customized blood sample collection kits to eligible veterans who are identified to Tasso by MVP. Tasso will distribute kits (outbound) to veterans and then will track the kits with the whole blood sample (in bound) to the kit’s destination, a third-party laboratory. According to Tasso literature, differing brands of in vitro diagnostic (IVD) tubes are compatible with the Tasso+ device. The MVP and Tasso will assure that laboratory system is compatible with the respective IVD. The laboratory will undertake the genomic analysis sequencing. Services is the majority cost and risk component of the contract; therefore, this contract will be processed as a services contract. There are two line items per performance year: On Demand Kits and Bulk Order Kits. On Demand Kits ship directly to veteran’s home. The veteran's blood sample is self-collected in the veterans’ home by the veteran. A pre-paid shipping label and secure container to return the whole capillary blood sample is included in the kit and creates an easy user experience for the veteran.

Each veteran will be able to order their customized blood kit at home from MVP with shipping from the proposed contractor, Tasso. Upon self-blood-collection, the kit is mailed by the veteran in a pre-labeled envelope an MVP-approved laboratory for genomic analysis and sequencing. In addition, Tasso will retain and provide to MVP all tracking information that is used to send the kits in bound to the veteran and out bound to the approved laboratory. The bulk ordering kits will be delivered to the VA Boston Healthcare System. Both line items are estimated (EST) items and are ordered on an as needed basis. The program office anticipates the greatest volume in the initial performance year.

This action is for a Firm-Fixed Price services IDIQ in support of the MVP research initiative with estimated quantities of approximately 9,750 to 20,000 units per year and estimated task orders. The five-

Effective Date: 02/01/2022 Page 2 of 4 year total estimated value is $5,460,000.000. The period of performance is from date of award, approximately February 17th, 2023, through five years from date of award.

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 41 U.S.C.

3204(a)(1) 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

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

Tasso does not offer its products through any mandatory source such as Federal Supply Schedule and Tasso does not resell its products to any authorized Veteran Owned Business. Both the contractor’s unique qualifications and the nature of the acquisition requires the use of the authority cited above (Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements).

Tasso’s unique qualifications apply to the micro-sampling Tasso+ Kit which includes three components: the Tasso+ Class II device, the IVD genomic DNA collection tube, and sundry additional collection materials (such as alcohol swabs and band aids)). While these latter components may appear mundane and are comparable to other brands, the kit is unique because of the primary, core device, a Class II FDA registered self-administered lancing device for one-time individual use with up to 600 (μl) microliters of capillary whole blood capacity. Other kits available on the market do not share the unique qualifications of Tasso’s product.

The prior history of the acquisition includes a CRADA (Cooperative Research and Development Agreement) titled “Million Veteran Program Specimen Collection” by VA Principal Investigator: Michael Graziano, M.D. This Pilot Study is referenced by Jessica Brewer, Million Veteran Program (MVP), Project Director. The study purchased 10,000 units through Boston VA Research Institute (BVARI), an affiliated nonprofit research and education 501(c)(3) corporation under 38 USC 7361-7366. The study resulted in successful results that have scientifically replicated the specimen collection as prominently as standard venous blood specimen collection. This program “has found that the quality of the specimen and resulting DNA is on par with the standard venous blood draw for MVP Participants”. All collection units are depleted from the pilot study and a succeeding contract is urgently needed. Additionally, any kit other than The Tasso+ Kit will foreseeably lead to delays and to substantial duplication of costs.

Tasso is the only firm capable of providing the services and product described above and an award to this contractor avoids delays and avoids substantial duplication of costs that could not be recovered through competition.

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

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The acquisition history was reviewed to ensure that offers were solicited from as many potential sources as practicable. The recommended course of action is a sole source award to Tasso. The contract acquisition history with Tasso commences with IDIQ 36C24E21D0006, which was awarded by Regional Procurement Office East for VA Puget Sound Healthcare System, Seattle Division. The Program Office and RPO East NCO 1 team worked closely with the administering personnel to gain access to the contract file to review their method of procurement. A Sources Sought Notice is documented, and it is also documented that only one response was received, and that was from Tasso (as per the file).

Competition was facilitated by the VA Boston Healthcare System MVP which identified that Tasso sold another kit that did not meet requirements for volume of liquid blood collection. MVP also identified a second vendor, Neotyrex, which however only collects capillary dry spot samples, and does not collect liquid capillary samples. These findings may also be found in the Market Research Report for this contract action.

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

The anticipated cost of $60.00 for Tasso+ Kits on demand is anticipated to be fair and reasonable as this price includes the complete logistics services which saves costs on shipment to and from each veteran and provides tracking for each of the three parties, MVP, Tasso, and the veteran. Tasso+ Kits could be purchased in bulk at $22.50/unit, however, the cost of using a third party (a current VA contractor) to ship and track would cost an additional $95.00/ unit. In contrast, with Tasso, for $60.00 per unit, both the product and the service are covered. The combination of product and service reduces cost, schedule, and performance risk. Considering similar acquisition history of contract 36C24E21D0006, the bulk price for each kit was $25.00, which is higher than what Tasso has offered here. Therefore, the costs of the Tasso+ kits and distribution and tracking are anticipated to be fair and reasonable.

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

Market Research Was Not Conducted:

Market research was conducted. Tasso, Inc, located at 1631 15th Ave West, STE 105, Seattle, WA

98119-2792. (UEI: JF2AG84MNZ77). Tasso, Inc. is a small business under NAICS 541614; Process, Physical Distribution, and Logistics Consulting Services. The PSC is R706 Support—Management:

Logistics Support. The Veterans First Contracting Program, Rule of Two cannot be met, as Tasso does not authorize any other company, mandatory source, and/or veteran owned business, to sell their products.

Confirmation to this extent was provided to Contracting. Tasso’s written assertion of exclusivity is in the contract file. Tasso is not a veteran owned business, which is documented in the file via DSBS and CVE.

Market Research documented additional information about the micro sampling device, the services and documented the acquisition history, and the CRADA history. The VA Rule of Two cannot be met, because the services are exclusive in nature, and any other acquisition strategy would result in substantial duplication of costs. These combined facts lead to the recommendation of a sole source award to Tasso.

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

An exception to the Competition in Contract Act is supported by the acquisition history, pricing, exclusive nature of service offering, and user feasibility. A statement of work has been developed and is in the file.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None.

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:

For future acquisitions of supplies or services any qualified vendor will be encouraged to identify itself to MVP for future comparable requirements. With that said, in due time, it is anticipated that a

Effective Date: 02/01/2022 Page 4 of 4 marketplace will exist with multiple vendors that provide these products and services. Researchers at VA continually search and monitor the market via trade shows, exhibitions, and journals for availability of services that can enhance their research. Principal Investigators and the VA Office of Research and Development welcome new entrants VHA research contracting opportunities. The VHA welcomes innovative solutions from the small business community to rapidly evolving research requirements. If more than one vendor provides products or services, competition will be encouraged, but here at VA, service-disabled veteran owned businesses and veteran-owned businesses will be searched for initially provided that there is compliance with the non-manufacturing rule and limitations on subcontracting.

As required by 41 USC 3404(f), Public Availability of Justification and Approval Required for Using

Noncompetitive Procedures, this justification shall be made publicly available on Contracting Opportunities at www.SAM.gov; results, if any, will be shared with the program office.

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.

Jessica Brewer Date MVP Project Director VA Boston Healthcare System Jamaica Plain

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.

William G. Healey II Date Contracting Officer VA Maine Healthcare System Togus

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

Joseph P. Maletta Date Executive Director Regional Procurement Office East (RPOE) VHA Head of Contracting Activity (HCA) http://www.sam.gov/ https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx