P03 SSJ- 36C241-20-AP-1689 - The Binding Site - T.Neubelt.JL --.pdf

OFOC SOP Revision 09 Page 1 of 4 Original Date: 03/22/11 Revision 09 Date: 04/17/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C241-20-AP-1689

1. Contracting Activity: Department of Veterans Affairs, Regional Procurement Office East (RPOE), New England Healthcare System, Network Contracting Office 1 (NCO1); Blanket Purchase Agreement (BPA) for the following seven (7) VA Medical Center Laboratories: Boston-Jamaica Plain/West Roxbury, VAHCS, Providence RI VAMC, West Haven CT VAHCS, Togus VAHCS Augusta ME, White River Junction VAMC VT, VAMC Manchester.

2. Nature and/or Description of the Action Being Processed: This procurement is for a new Firm- Fixed Price five-year-BPA for The Binding Site, Inc. Optilite Protein Analyzer and associated reagents, together with full maintenance and support including upgrades (Silver Level service pack). The total BPA value is $866,431.00. The Period of performance is 6/15/2020 - 6/14/2025. This testing will be performed at the VAMC West Roxbury VA Immunology lab for all VISN 1 sites.

3. FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is for an Optilite Protein Analyzer and Reagents in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

4. Description of Supplies/Services Required to Meet the Agency’s Needs: This requirement is for the equipment and reagents required to identify the special proteins related to multiple myeloma in Veteran patient cancer diagnosis. Specifically, testing of Free Light Chain Lambda and Kappa proteins as well as HevyLITE™ Assays of Light Chain proteins of Immunoglobulin G (IgG), Immunoglobin M (IgM) and Immunoglobin A (IgA) are required. The Binding Site, Inc., is the sole source provider for the HevyLITE™ reagents, and the Optilite Protein Analyzer that are used for this testing. The Binding Site, Inc. is the only vendor whose polyclonal assays are FDA approved for diagnosing and monitoring for therapy or disease progression. The technology is proprietary to The Binding Site, Inc., a small business.

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

(X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3;

( ) (4) International Agreement per FAR 6.302-4 ( ) (5) Authorized or Required by Statute FAR 6.302-5;

( ) (6) National Security per FAR 6.302-6;

( ) (7) Public Interest per FAR 6.302-7;

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6. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): In accordance with Far part 6.302- 1, The Binding Site, Inc. is the only company with an polyclonal assay that has FDA approval for diagnosing and monitoring the progression of disease within a patient, or his or her response to treatment, by following the Free Kappa and Lambda light chain isotope testing results. They are also the only company that has HevyLITE™ proteins that can help providers determine when a treatment has stopped working for their Multiple Myeloma patients. The test provides rapid and accurate results that play an important role in monitoring response to treatment. HevyLITE™ is made specifically for use with the Optilite Analyzer. No other vendor offers an FDA approved product for this purpose. The Binding Site, Inc. is also the sole distributor for this equipment and the proprietary reagents.

7. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Research by the VA Boston lab has revealed that Abbott Diagnostics and Siemens, both large businesses, are the only other vendors that are FDA approved for Free Lambda and Free Kappa testing. However, their products are not FDA cleared to monitor the follow up testing that may tell the Clinician the progress of the disease. This inability would mandate creation of a Lab Developed Test (LDT). Further research found that Siemens offers a product called Nlatex, which is a light chain assay. However, it is not found to be used in the US. Although it is FDA approved, it is a monoclonal Assay, which has been attributed to missed diagnosis. A few Siemens tests were tried in Canada but stopped because of poor performance and misdiagnosis of patients.

There was no College of American Pathologistics (CAP) peer group established for evaluating effectiveness of the Siemens testing. No vendor other than The Binding Site Inc. offers HevyLITE™ testing.

8. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: These reagents are currently on an existing VISN1 contract which is based on 4% pricing increases from years two through five. The year five increase was not exercised in 2019.

Pricing within the new agreement will be held to the current agreement pricing for the first year.

This is therefore the original agreement’s 2018 pricing. Binding Site, Inc. has agreed to lower annual pricing increases from 4% to 3% ( a $1,732.00 annual savings). Windows upgrades to the current equipment on site will be at no charge (normal upgrade charge is $3,000.00). The Binding Site, Inc.

will also be providing equipment based on previous pricing; a savings of $44,000.00, or 55%. Pricing on equipment and reagents has therefore been determined to be fair and reasonable to the VA.

9. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Research was conducted and it was determined that only The Binding Site Inc. was able to completely meet the requirements identified in the Statement of Work, and having the FDA approvals required by the VA .

10. Any Other Facts Supporting the Use of Other than Full and Open Competition: The Binding Site, Inc. is the only vendor that can meet these needs in our VISN 1 Laboratory sites. The testing using the Optilite Analyzer vs the former SPA Analyzer, will save the VA costs on some patients due to previous higher dilution protocols for the SPA Analyzer. Fewer dilutions requires less reagents used on patient testing, and fully automated test eliminates manual effort and quality issues. The Optilite

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Protein Analyzer is currently in use. Switching to another Analyzer would add additional cost and involve extensive testing and validation while not meeting the needs of this requirement.

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

12. 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 Cor will continue to monitor new technology and if additional comparable sources are found in the future, this requirement may be competed.

13. 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 David McElwee Date Title Program Support NCL Facility -VA Brockton

14. 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.

Name: Julie Lemire Date Title: Contracting Officer Facility: VAMC Manchester Contracting Office

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Date

David G.

McElwee 142454

Digitally signed by David G. McElwee 142454 Date: 2020.05.28 11:25:46 -04'00' 5/28/2020

5/28/2020 Julie A. Lemire 149432

Digitally signed by Julie A.

Lemire 149432 Date: 2020.05.28 12:12:37 -04'00'

Linda J. Ward Digitally signed by Linda J.

Ward 155235 Date: 2020.05.28 13:41:27 155235_____________________________-04'00'

Name: Linda Ward Branch Chief Facility: VAMC Manchester Contracting Office

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HIGHER LEVEL APPROVAL (Required for orders over $700,000):

c. Concurrence / Non-concurrence

Name: Tammy Fox Date Division Chief (NCO1)

d. 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 recommend approval (if over $68 million) or approve ($700K to $68 million) for other than full and open competition.

Date

Name: Joseph P. Maletta Executi e Director, egional Procur ment Office- East (RPO-E)

Tammy A Fox 706200

Digitally signed by Tammy A Fox 706200 Date: 2020.05.28 14:39:48 -04'00'

JOSEPH MALETTA

1347841

Digitally signed by JOSEPH

MALETTA 1347841

Date: 2020.05.28 16:38:50 -04'00'