36C25023Q0469.docx

SUBJECT*

OptiLite Instrumentation and Reagents Lab Diagnostics for Cincinnati VAMC

GENERAL INFORMATION

BASE NOTICE TYPE

SET-ASIDE

CONTRACTING OFFICE ADDRESS

Department of Veterans Affairs Network Contracting Office 10 1700 E 38th Street Marion IN 46953

POINT OF CONTACT*

Contract Specialist Lillie Grey lillie.grey@va.gov 765-677-6112

AWARD INFORMATION

AWARDEE ADDRESS LINE 1*

AWARDEE ADDRESS LINE 2*

AWARDEE ADDRESS LINE 4*

ADDITIONAL INFORMATION

DESCRIPTION

Notice of Intent to Sole Source Requirement

Department of Veterans Affairs, NCO 10 Contracting in Marion, IN 46953, intends to negotiate an open market sole source contract under FAR (FAR 13.106-1(b)(1)(i), FAR 6 and FAR 18.1-2 Only One Responsible Source for these brand name/proprietary analytical instrument and consumable supplies listed below is only available through the original equipment manufacturer.

The associated NAICS code for this is 325413. The vendor will be The Binding Site, Inc., 6730 Mesa Ridge Road, San Diego, CA 92121

Description of Equipment or Supplies:

IE700 Optilite® Analyzer, Kits, Various Reagents & Consumable Supplies

A firm fixed price contract with four option years is anticipated and shall be awarded. It is the Government's belief that only the proposed candidate possesses the required capabilities to successfully meet this requirement. It is the Government's intention to solicit and negotiate with only this source.

This notice of intent is not a request for competitive proposals. It is not a solicitation or request for offers.

See the attached Sole Source Justification Award Notice Award Notice

*= Required Field Award Notice Award Notice

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C250-AP-1023

1. Contracting Activity: Department of Veterans Affairs, VISN 10, Cincinnati VA Medical Center The Department of Veterans Affairs VISN 10 contracting officer shall be responsible for the proposed contracting action. EER 170376

2. Nature and/or Description of the Action Being Processed: This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501).

The procurement is for a Base contract plus 4 option years for instrumentation and reagents to be used for specialized immunology testing. The procurement request is for a reagent rental/leasing agreement in which the Optilite analyzer including PC, monitor, printer, and UPS are included.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: Currently the Pathology and Laboratory Medicine Service is sending out all free light chain testing to a reference laboratory, contributing to increased costs of testing and delays in test turnaround times. Bring the Optilite platform in-house will decrease costs, improve turnaround times of test reporting which will improve the overall treatment of the patients. The additional benefit of adding on addition assays that are currently sent out such as Beta 2-microglobulin and Alpha 1-antitrypsin are of increased benefit.

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): The Optilite analyzer is a highly specialized platform that performs testing specific to diagnose or rule all types of monoclonal

VHAPG

Part

813.5

Simplified

Acquisition

Procedures for

Certain

Commercial

Items Attachment

1:

Request for

Sole

Source

Justification

Template

>SAT-$7.5M

under

FAR13.5

Effective

Date:

02/01/2022 Page of gammopathies. Binding Site is the sole proprietor (only responsible source) of the FDA approved free Kappa light chain and free lambda light chain reagents (Freelite®) in the United States.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable. Inquiries have been made to other VA laboratories for potential sources. No other potential sources identified. Binding Site issued a letter of declaring the required reagents are only available from Binding Site.

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

Base plus 4 option years: May 1, 2023 to April 30, 2028 Product Code and Description IE 700 (Optilite® Analyzer including PC & Monitor)

· OPTILITE SILVER Service (Year 1 Warranty no charge)

· LK016.OPT.A (Free Kit for Optilite® )

· LK018.OPT.A (LFree Kit for Optilite® )

· NK010.OPT.A (IgA Kit for Optilite®)

· NK004.OPT.A (IgG Kit for Optilite®)

· NK012.OPT.A (IgM Kit for Optilite®)

· NK023.OPT.A (Hu C3c Kit for Optilite®)

· NK025.OPT.A (Hu C4 Kit for Optilite®)

· LK043.OPT.A (Beta-2-microglobulin Kit for Optilite®)

· NK034.OPT.A (Alpha 1 Antitrypsin for Optilite®)

· NK004.L.OPT.A (IgG CSF)

· IK709 (Optilite® Diluent 1)

· IK710 (Optilite® Diluent 2)

· IK711 (Optilite® Diluent 3)

· 989220 (Sample Cups 0.5ml )

· 989221 (Sample Cups 2ml)

· IK702 (Optilite Cuvettes TENCELL)

· IK703 (Washing Solution 20 ml)

· IK704 (Washing Solution 100 ml)

· IK705 (Tubing Maintenance Solution 20 ml)

· IK707 (Special Wash)

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Vendor inquires, emails to Vendor Sales Representatives, Sales Representative on-site meetings, GSA Advantage inquires, Vendor Catalogs and brochures, inquires to other VA laboratory subject matter experts were used to determine prospective vendors. Cost of item based on the product description, product capabilities, instrument maintenance, training requirements, installation, utility requirements, safety requirements were assessed in market research.

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

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

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: Toward the end of the contract period, the service will conduct the market research to determine if additional suppliers are available to meet the testing needs of the service. If it is determined additional suppliers exist providing a platform that will perform FDA approved methods for all the required testing, the service may submit the contract for competitive bidding.

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.

KEITH JACKSON

Digitally signed by KEITH JACKSON Date: 2023.02.01 11:44:09 -05'00'

Page 1 of

Name Keith Jackson Date 02/01/2023 Title Inventory Management Facility 539

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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. Purchase is approved in accordance with FAR13.106-1(b).

Page 1 of

RHONDA FITZGERALD

Digitally signed by RHONDA FITZGERALD Date: 2023.02.01 11:50:59 -05'00'

Page 1 of Name Rhonda L Fitzgerald Date 02/01/2023 Title Contracting Specialist Facility 583

a. 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.

Digitally signed by CHRISTOPHER

CHRISTOPHER BLAZEJEWSKI BLAZEJEWSKI

Date: 2023.02.01 16:51:17 -05'00'

Name Christopher Blazejewski Date 02/01/2023 NCO 10 Duty Title Contract Officer Facility 539