PM_Part813.106_Atch1_SingleSourceJustification_MPT-SAT betasam.pdf

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

VHAPM Part 813.106 Page 1 of 2 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: ________ 36C242-21-AP-1979______________

1. Contracting Activity: Department of Veterans Affairs, VISN 02, VA New Jersey Healthcare System

(561), 385 Tremont Ave, East Orange, NJ 07939

2237: 561-21-3-3086-0071

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

Chief of Neurology Service at VA New Jersey Health Care System (VANJHCS) in VISN2 is requesting Brand Name purchase of a Millipore Milliplex FlexMAP 3D multiplex immunoassay system utilizing the Luminex technology to carry out experiments to detect simultaneously a large number of proteins in a single biological sample to assess changes the brains in these disorders and treatment effects.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

MilliPlex FLEXMAP 3D’s unique characteristics:

• To assess a large number of analytes in a single biological sample, one requires Luminex technology.

• FlexMAP 3D is Luminex’s most advanced and versatile multiplex platform assessing up to 500 analytes through the combination of differentially dyed fluorescent microsphere sets.

• Higher Throughput: Dual sample fluidics paths and increased sample injection speed result in a faster sampling rate. The FLEXMAP 3D System can process 384 samples and generate up to 144,000 data points in just over an hour.

• High-Plexing Capability: The FLEXMAP 3D is compatible with magnetic and non-magnetic microspheres and can discriminate up to 500 different microsphere sets. The platform offers a large menu of commercial kits and reagents to develop custom assays for a wide variety of applications including nucleic acid assays, immunoassays, receptor ligand assays, and enzymatic assays.

• Automation/LIS Compatibility: xPONENT® Software controls the FLEXMAP 3D System and offers interfacing options for Laboratory Information Systems (LIS) and front-end automation platforms.

The system accommodates 96 and 384-well plate formats for enhanced sample flexibility and increased throughput.

https://www.acquisition.gov/?q=/browse/far/13

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

VHAPM Part 813.106 Page 2 of 2 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

• Reliability: The FLEXMAP 3D System has multiple features allowing walk away start-up, shut-down, and maintenance operations, and greatly enhances usability for High Throughput Screening (HTS) applications.

• Key Features: Multiplexing: Up to 500 analytes in a single sample. Dynamic Range (Typical): ≥4.5 logs. Read Time: 96-well plate in ~20 min (up to 144,000 tests/hour); 384-well plate in ~75 min (up to 153,600 tests/hour). Daily Start-Up/Shut-Down: ~30 min.

4. Description of market research conducted and results or statement why it was not conducted:

Market research was conducted by reviewing major manufacturers websites, review of product literature, technical discussions with application specialists from the company on multiplex immunoassay system. No other systems will provide the exact same specifications required by the investigator and research project. MilliPlex FLEXMAP 3D Luminex technology-based multiplex immunoassay system meets the Government's requirements. After reaching out directly to the manufacturer it was discovered that there are two authorized SDVOSB distributors of the MilliPlex FLEXMAP 3D manufactured by EMD Millipore and Luminex, Stripes Global Inc. and Franklin Young International, Inc.

5. BRAND NAME ONLY: This buy is estimated to exceed $25,000 and this documentation will be posted along with the RFQ on betasam, as required by FAR 5.101 (a).

6. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Name Date Title

• MILLIPLEX MAP kits have the broadest selection of analytically validated protein analytes across a wide range using the Luminex technology.

• MILLIPLEX Belysa analysis software package provides user-friendly options to facilitate the analysis of the data acquired using FlexMAP 3D.

https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466