P03 SSJ JA_OVER_SAT Abbott SARS-CoV-2 Ab Reagents.JL.3.22.2021--NOI.pdf

VHAPM Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 4 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID:_Planning UID: VA-21-00047769 Contracting UID: 36C241-21-AP-1504

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO 1), VAMC Manchester, 718 Smyth Road, Manchester NH 03104

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

Create a follow on to BPA# 36C24120A0039 expiring 4/22/21, COVID-19 Emergency requirement of “as needed” orders for Abbott SARS-Co-V-2 Antibody reagents for testing to aid in managing patients and maintain quality healthcare during the Coronavirus Disease 2019 (COVID-19) pandemic for a one year period. These reagents will be used on our current Abbott Architech &/or Abbott Alinity instrumentation throughout VISN 1. Total estimated cost: $445,388

Name of Proposed Contractor: Abbott Street Address: 100 ABBOTT PARK RD DEPT 943 BLDG AP6C-3 City, State, Zip: NORTH CHICAGO IL 60064 Phone: 1-562-240-6500

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This is a COVID-19 Emergency sole source requirement for COVID-19 Antibody Test kits to run on existing equipment which is proprietary to the manufacturer of these kits. This will require the following:

Item

Product # Product Description Qty Price Extended

Amount 1 06R86-20 Architect IA SARS-CoV-2 IgG Reagent (100 tests) 282 $ $ 2 06R86-30 Architect IA SARS-CoV-2 IgG Reagent (500 tests) 0 $ -$ 3 06R86-01 Architect IA SARS-CoV-2 IgG Calibrator Kit (US) 88 $ $ 4 06R86-10 Architect IA SARS-CoV-2 IgG Control Kit (US) 120 $ $ 5 06R8720 Architect IA SARS-CoV-2 IgM Reagent (100 test/kit) 100 test kits 232 $ 6 06R87-01 Architect IA SARS-CoV-2 IgM Calibrator (US) 76 $ $ 7 06R87-10 Architect IA SARS-CoV-2 IgM Control (US) 108 $ $ 8 6S60-20 Architect AdviseDx SARS-CoV-2 IgG II Reagent Kit (100 tests) 314 $ $ 9 6S60-30 Architect AdviseDx SARS-CoV-2 IgG II Reagent Kit (500 tests) 0 $ -$

10 6S60-01 Architect AdviseDx SARS-CoV-2 IgG II Calibrator Kit (1 vial x 6 levels) 88 $ $ 11 6S60-10 Architect AdviseDx SARS-CoV-2 IgG II Control Kit (1 vial ea, pos 1, pos2, neg) 120 $ $ 12 6S6120 Alinity AdviseDx SARS-CoV-2 IgG II Reagent Kit (200 (100x2) test kit) 0 $ -$ 13 6S6130 Alinity AdviseDx SARS-CoV-2 IgG II Reagent Kit (1000 (500x2) test kit) 0 $ -$ 14 6S6101 Alinity AdviseDx SARS-CoV-2 IgG II Calibrator Kit (1 vial x 6 levels) 0 $ -$ 15 6S6110 Alinity AdviseDx SARS-CoV-2 IgG II Control Kit (1 vial ea, pos 1, pos2, neg) 0 $ -$

The total estimated cost is $445,388 *Note: Items shown as “0” Qty here and on the IGCE are place holders in case sites need to utilize these reagents in the future. The Statement of Work lists these items as 0-1 for that purpose and should not be part of the cost estimate. If sites use these reagents in the future, they would be discontinuing use of one of the other reagents, so the cost balances out.

4. Statutory Authority Permitting Restricted Competition:

PM Part 813.5 SAP for Certain Commercial Items Page 2 of 4 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

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):

VISN 1 is already live with this testing, which means sites have already performed and approved the validation studies required by accreditation agencies prior to performing patient testing.

This is a follow-on request to continue VISN 1’s ability to offer SARS-COV-2 antibody testing to our staff and Veterans without disruption as the COVID-19 pandemic continues. Abbott has the only U.S. Food & Drug Administration (FDA) Emergency Use Authorization (EUA) SARS-Co-V-2 antibody test that can be performed on the Abbott equipment we currently have in house.

Abbott is the only manufacturer and distributor of the Abbott reagents.

Laboratories are regulated by the Clinical Laboratory Improvement Amendments (CLIA) administered through the Centers for Medicare Services. The VA has an additional laboratory oversight body. The use of tests or reagents for purposes NOT approved by the FDA is strictly prohibited by federal law and VA policy without the performance of an exhaustive validation study.

Due to the urgency of the pandemic, such a validation study cannot be performed to use other assays in these capacities. Use of any other assays for SARS-CoV-2 antibody testing in the same manner as the Abbott SARS-CoV-2 antibody assay would violate federal law.

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

N/A – no other offers were solicited since this is a follow-on to BPA # 36C24120A0039 awarded 4- 23-20 as an emergency during COVID-19 for SARS-CoV-2 antibody testing reagents.

We are still in the midsts of the pandemic and there is still a need for this testing. Abbott is the sole manufacturer and distributor for the FDA/EUA Abbott SARS-CoV-2 antibody reagents.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Abbott is keeping the pricing the same as the current BPA pricing which was determined to be fair and reasonable at the time of initial award 4/23/20. Additionally, Abbott is working to add these reagents to their Federal Supply Schedule offering.

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8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Market Research was not conducted. VISN 1 is already live with this testing. It would not make sense or benefit the VA to purchase another vendor’s equipment and reagents to perform this testing. Doing so would be costly, reduce efficiency by introducing another testing platform into the workflow of the limited laboratory staff, and would result in an interruption of services while the laboratory receives in new equipment (due to supply chain issues as a result of the pandemic), and performs the required validation studies prior to being allowed to perform patient testing.

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

Emergency status of COVID-19 testing requirements of veterans.

VISN 1 has been using Abbott Architect instruments for chemistry and immunoassay testing for over 10 years. SARS-CoV2 antibody testing was added to the Abbott Architect platform as 2020 in response to the pancemic, and only Abbott reagents are acceptable for this platform.

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

N/A. No other manufacturer can provide the reagents we need to perform SARS-CoV-2 antibody testing on our in-house Abbott equipment. No other sources were sought due to the sole source nature of requirement.

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: This is a one year emergency requirement due to the COVID-19 pandemic that has the potential to be incorporated into our current Abbott Architect contract if Abbott adds this testing to their Federal Supply Schedule. If they do not add it to their FSS, VISN 1 will consider if other instrumentation/testing options are viable when determining how we will perform this testing at the end of this 1 year period.

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.

Name: Janet Lane Date Title: Network Consolidated Laboratory Program Director Facility: VISN 1

Janet L. Lane 150483 Digitally signed by Janet L. Lane 150483 Date: 2021.03.19 15:48:13 -04'00'

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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.

Name: Julie Lemire Date Title: Contracting Officer Facility: NCO1 – Manchester VAMC

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.

Name: Linda Ward Date NCO1 Branch Chief – Supply 1

Facility: NCO1 – Manchester VAMC

Julie A. Lemire 149432 Digitally signed by Julie A. Lemire 149432 Date: 2021.03.21 17:25:23 -04'00'

Linda J. Ward 155235 Digitally signed by Linda J. Ward 155235 Date: 2021.03.22 14:44:16 -04'00'