Justification - FAR 13.5 - Sole Source - 36C257-23-AP-4462 - Redacted.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification >SAT-$7.5M under FAR13.5 JOFOC Tracking #: 2023-09-06T06:50:47

Effective Date: 02/01/2022 Page 1 of 3

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C257-23-AP-4462

1. Agency: Department of Veterans Affairs (VA)

Contracting Activity: Network Contracting Office 17 5441 Babcock Rd., Ste. 302 San Antonio, TX 7240

Purchase Request Number: 674-24-1-034-0018

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

Network Contracting Office 17 (NCO-17) intends on awarding an open market firm-fixed price indefinite-delivery indefinite-quantity (IDIQ) contract as sole source to The Binding Site for a cost-per consumables analyzer rental program at the Central Texas Veterans Health Care System. The contract will have a base period and four one-year option periods.

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

The contractor shall provide a fully automated, random access, FDA approved instrumentation to the government. Reagents, controls, calibrators, and validation materials to support Kappa and Lambda Free Light Chain testing, Beta-2-Microglobulin, Ceruloplasmin, C3, C4 and Rheumatoid Factor testing are supplied via reagent rental pricing. The entire analyzer system will be serviced, supported, and supplied through a single contractor, including any parts, equipment, or supplies not manufactured, provided, or serviced by the contractor.

Estimated value, to include all options: $REDACTED.

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

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

Attachment 1: Request for Sole Source Justification >SAT-$7.5M under FAR13.5 JOFOC Tracking #: 2023-09-06T06:50:47

Effective Date: 02/01/2022 Page 2 of 3

A sole source letter provided by the Binding Site states that all diagnostic and monitoring criteria in the ‘International Myeloma Working Group Updated Criteria for the Diagnosis of Multiple Myeloma’, relative to serum free light chains (sFLC) assays, were determined using Binding Site Freelite® assays. Due to the lack of an international standard for serum free light chain testing, sFLC assays are not standardized and are not interchangeable.

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

A special notice, notice of intent to award a sole source procurement, was posted on the System for Award Management, Contract Opportunities, under 36C25723Q1345 on 8/25/2023. The notice stated that all responsible sources could submit a statement, proposal, or quotation that shall be considered by the agency. The notice response date of 9/1/2023 has passed and there were no responses to the notice.

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

The contracting officer has determined that the anticipated proposed prices will be fair and reasonable. The contracting officer will compare the proposed prices with those prices found reasonable in the current contract to determine price fair and reasonable.

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

Market Research Was Not Conducted:

A search of the mandatory sources for procurements of supplies, UNICOR and Ability One, revealed that they do not offer the requested supplies/services. A search of Regional Procurement Office West’s Western States Network Consortium’s blanket purchase agreements and contracts revealed that they do not offer a contract vehicle for the requested supplies/services. A search of GSA Advantage identified that there are eight VA NAC contract holders that offer chemistry cost-per-test programs to the VA. A search of the SBA’s Veteran Small Business Certification (VetCert) identified that there are 194 veteran-owned businesses that utilize NAICS code 334516 as a capability. A search using the SBA’s Dynamic Small Business Search tool did not identify a small business that offers the requested supplies/services.

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

None

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:

The major barrier to competition is that there is not an international standard for free light chain testing. Market research will be performed prior to exercising options and on subsequent procurements to see if there have been any changes in the market.

Attachment 1: Request for Sole Source Justification >SAT-$7.5M under FAR13.5 JOFOC Tracking #: 2023-09-06T06:50:47

Effective Date: 02/01/2022 Page 3 of 3

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.

//SIGNED// 9/11/2023

REDACTED Date:

Chief Technologist Pathology & Laboratory Medicine Service Central Texas Veterans Health Care System

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.

Contracting Officer

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.

Branch Chief, Laboratory Support Team Network Contracting Office 17 https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx