P03 LSJ - PM_Part808.405-6_Atch2_ OVER_SAT Abbott Alinity M.DMT.rev2 -.pdf

VHAPM Part 808.405-6 Limiting Sources Page 1 of 4 Original Date: 08/30/2017 Revision 02 Eff Date: 02/21/2020

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C241-21-AP-0128

(1) Contracting Activity: Department of Veterans Affairs, VISN 1, Connecticut Medical Center

2237: Primary Virus Detection Reagents for Abbott Alinity M Analyzer 689-21-1-7455-0097, Total Value: 684,432.44

(2) Description of Action: 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). ).

VISN 1 is seeking a firm fixed price Delivery Order for reagents and supplies from Abbott Molecular for performing Human immunodeficiency virus (HIV), Hepatitis C virus (HCV), Hepatitis B virus (HBV), and SARS-Co-V-2 nucleic acid detection testing at the Veterans Affairs Connecticut (VACT) Virology Lab, which serves as the Reference lab for all VISN 1 labs for this testing. A one-year Delivery Order is being requested with a Period of Performance: November 1, 2020 – October 31, 2021.

This will be awarded as follow on requirement for testing Reagents required for virus detection performed on the Abbott Alinity M Analyzer awarded with Purchase Order# 36C24120P0934.

Order against: FSS Contract Number: V797D-40222

Name of Proposed Contractor: Abbott Molecular Street Address: 1300 E. Touhy Ave City, State, Zip: Des Plaines, IL 60018 Phone: 1-224-361-7865

(3) Description of Supplies or Services:

The estimated value of the proposed action is $ 684,432.44

Reagents and supplies from Abbott Molecular for performing HIV, HCV, HBV, and SARS-Co-V-2 PCR testing at the VACT Virology Lab, which serves as the Reference lab for all VISN 1 labs for this testing.

Period of Performance: 11-1-2020 to 10-31-2020

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

VHAPM Part 808.405-6 Limiting Sources Page 2 of 4

Revision 02 Eff Date: 02/21/2020

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

COVID19 testing reagents are very scarce and available on allocation only, other virus detection testing is currently shutdown in VISN1 due to current supply shortages

FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

Abbott is the only vendor who can currently provide the reagents for HIV, HCV, HBV, and SARS-Co-V-2 testing on the Abbott Alinity M analyzer.

Laboratories are regulated by the Clinical Laboratory Improvement Amendments (CLIA) administered through the Centers for Medicare Services (CMS). The VA has an additional laboratory oversight body, VA Pathology & Laboratory Medicine Enforcement Office, and maintains College of American Pathologists (CAP) accreditation. 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. Such a validation study cannot be performed using any other reagents in these FDA approved assays. Use of any other reagents on the Abbott Alinity System would violate federal law.

FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

This will be awarded as follow on requirement for testing Reagents required for virus detection performed on the Abbott Alinity M analyzer awarded in contract 36C24120P0934.

FAR 8.405-6(b): Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition.

The proprietary data is Abbott is the only vendor who can currently provide the reagents for FDA approved HIV, HCV, HBV, and SARS-Co-V-2 assays for testing on the Abbott Alinity M Analyzer.

These are “direct replacements” parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing.

The Abbott Alinity M Analyzer was awarded with contract 36C24120P0934 and Abbott is the only vendor who can provide the reagents/supplies/consumables for testing on the Abbott Alinity M Analyzer.

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Revision 02 Eff Date: 02/21/2020

(5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination:

Having onsite testing has great value to quality patient care, the current pandemic has made virus testing reagents very scarce. VACT Pathology and Laboratory medicine service currently has 4 testing platforms for COVID-19 PCR testing, only the Roche 6800 is a high-volume analyzer, but testing reagents have been very limited, restricting access to testing. The other high-volume analyzer is Alinity M. Having a second pathway for high volume COVID-19 testing will ensure VA’s ability to maintain COVID-19 testing in light of several manufacturer specific supply chain interruptions.

This procurement request will provide VACT Virology Lab with guaranteed availability of these scarce supplies, ease of ordering, and fair pricing and thereby providing our veterans with continued service without interruptions. Due to consideration of historical pricing, it was determined that pricing is fair and reasonable. Accordingly, Abbott is the only firm capable of providing the reagents and supplies described in Section III above on the previously purchased Alinity M analyzer. No amount of additional research could be expected to further reduce costs through competition and would result in unacceptable delays in fulfilling this requirement, especially critical during the COVID-19 pandemic. The Alinity M analyzer acquisition began in July and now in October to attempt to find and bring in another analyzer, would be very costly and time consuming to the government with no recognizable benefit to be obtained.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

Market Research was not conducted because the Abbott Alinity M System is already purchased at VA CT, Virology Lab and used for Reference Lab testing for VISN 1 patients and are FDA approved. Due to the current COVID-19 pandemic, there is an urgent need to expand virus testing so as not to interrupt patient care.

These reagents, along with this testing platform maximizes lab productivity by reducing hands-on time along with its automation.

The reagents are barcoded and packaged in ready-to-use spill-proof cassettes. These reagents are only supplied by this manufacturer. No further technical market research is required since the reagent and supplies are only provided by the Manufacturer and the analyzers are already purchased by the Veterans Health Administration

(7) Any Other Facts Supporting the Justification:

VACT Pathology and Laboratory medicine service currently has 4 testing platforms for COVID-19 PCR testing, only the Roche 6800 is a high-volume analyzer, but testing reagents have been very limited, restricting access to testing. The other high-volume analyzer is Alinity M. Having a second pathway for high volume COVID-19 testing will ensure VA’s ability to maintain COVID-19 testing in light of several manufacturer specific supply chain interruptions.

This testing increases the efficiency and service provided by the VA CT Virology Lab to the other labs within the VISN and is much less labor intensive than other systems.

VHAPM Part 808.405-6 Limiting Sources Page 4 of 4

Revision 02 Eff Date: 02/21/2020

(8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made:

If there becomes a time, despite the pandemic, or when the pandemic subsides, where it makes sense to review and investigate alternative testing methods for virology testing in VISN 1, the laboratory will perform appropriate market research and review all available options in accordance with Contracting guidelines.

(9) 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. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

SIGNATURE DATE

Dana Towle Manager Pathology & Lab Med

NAME TITLE SERVICE LINE/SECTION

VA Connecticut

FACILITY

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

CONTRACTING OFFICER SIGNATURE DATE

Julie Lemire, Contracting Officer NCO1 – Manchester VAMC

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $700K):

I certify the justification meets requirements for other than full and open competition.

SIGNATURE DATE

Linda Ward – Branch Chief, Supply Team 1 NCO1 – Manchester VAMC

Julie A. Lemire 149432 Digitally signed by Julie A. Lemire 149432 Date: 2020.10.23 09:48:46 -04'00'

Dana M Towle 124655 Digitally signed by Dana M Towle 124655 Date: 2020.10.23 09:55:00 -04'00'

Linda J. Ward 155235 Digitally signed by Linda J. Ward 155235 Date: 2020.10.23 10:28:36 -04'00'