36C25623Q1264_2_JA Redacted.pdf

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

Last Updated: 02/01/22 Page 1 of 3

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:

1. Contracting Activity:

Department of Veterans Affairs, VISN 16, Michael E. DeBakey VA Medical Center (MEDVAMC) #580 located on 2002 Holcombe Boulevard Houston, TX 77030: Funding Document number is

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

MEDVAMC is requesting to procure a Brand Name only Autoimmune FastTrack 3100 and Image Navigator ® Automated Microscope IN110 being purchased is a critical component in processing Autoimune disease tests in Microbiology. Autoimmune disease hap defen to mistakenly attack normal cells. The items that are required are: Image Navigator ® Automated Microscope includes 1 Microscope w/ motorized stage, LED, 4x, 20x and 40x objectives; 1 Computer w/ monitor, joystick, mouse, and keyboard; 1 Software Sorting Module to sort Negative / Positive ANA Patterns; and 1 10X objective and Autoimmune FastTrack 3100 Sample Processing Station Sample Processing system for slide and automated prep. To include 4 Sample Rack w/ mirror; 1 Reagent & Control Rack; 1 Microtube and Slide Rack; 1 Integrated 1D/2D barcode reader for specimen processing; 1 System includes a Dell Desktop Computer, Monitor & Windows Operating System; and also includes a hotel and airfare for two techs to Dallas for proper training on the instruments. Estimated Amount:

Key Features:

Capable of sharing system fluids(reagents) Capable of sharing incubation times for multiple samples Capable of running multiple assays simultaneously Minimal user maintenance Ability to load samples and walk-away from the system Sample Tube Capacity of 96 Footprint (D x W x H in inches) of 2- x 29 x 33 Capable of Running ELISA o Capacity of up to 3 plates

10 Reagent Positions 12 Control Positions Bullet Tube Serial Dilution Prep Method Throughput for Maximum Samples (min) of 105 Capable of running 6 different tests together FDA-cleared automated microscope Pattern Assisted Learning

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Test Capabilities:

HEp-2000 ANA o Capable of COLORZYME

HEp-2 ANA o Capable of COLORZYME

Ndna o Capable of COLORZYME

ANCA Ethanol HISTOFLUOR EmA HISTOFLUOR rodent (Liver/Kidney/Stomach) ANCA (antineutrophil cytoplasmic antibodies) Formalin Capable of ELISA (enzyme-linked immunosorbent assay) o ANA Screen o ENA Single-Well Screen o ENA Multiparameter o MPO o PR3 o Cardiolipin IgG & IgM o dsDNA

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

MEDVAMC currently uses the AFT3100, the addition would interface with what the facility already owns. To purchase a different brand would cause the facility an additional requirement of creating a new Standard Operating Procedure (SOP) and time spent training on the new equipment. The cost and delay caused by required training on new equipment would cause a delay in delivering patient care. The AFT3100 is the only automated instrument capable of performing multiple tests simultaneuously that has Pattern Assisted Learning and a FDA-cleared automated microscope. As there are more than 80 types of autoimmune diseases that affect a wide range of body parts. If an autoimmune disorder is left untreated, it can lead to more serious complications and even death. In addition, the person will also run a higher risk of infections. AutoImmune Diagnostic tests screen for antinuclear antibodies, which are a category of antibodies that attack the healthy proteins within the cell nucleus. All of which allow Microbiology to yield an accurate timely laboratory result which enables earlier informed decision making by medical personnel for treatment planning. The Microbiology laboratory has historically done this workflow manually. Per GAO decision B-290414, B-411904, and B-416195 where, as here, a requirement relates to human safety concerns, the agency has the discretion to set its minimum needs so as to achieve not just reasonable results, but the highest possible reliability and effectiveness. Therefore, the brand name only approach is substantiated.

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

June 9, 2023, an RFI/ Sources Sought was posted to the SAM website with the responses requested by June 14, 2023. The posting remains available until June 28, 2023, prior to archiving. The intent of

Last Updated: 02/01/22 Page 3 of 3 the RFI was to 1) Determine the availability of sources who could provide the exact brand name items and 2) Determine the availability of sources who could provide items determined to be equivalent to the brand name items. The posting was essentially an intent to establish sources and it was stated in the RFI that responses would be used to determine the future formal procurement strategy. Two RFI response was received from a source capable of delivering the exact brand name products; Branch Medical LLC (HMAKT7YKT4L4) SDVOSB an authorized distributor of and Black Olives Company (NWCZAPN5KBW4) SB who did not provide an authorized letter and was not confirm by OEM. DLA ECAT searched with key items #AFT3100 with no results and #IN110 with one result found, available for order under DLA SPE2DE21D0032. AFT3100 not available under contract.

VA SCMC searched with key items #AFT3100 and #IN110 with no results found. Ability One searched with key items #AFT3100 and #IN110 with no results found. Interagency Contract Directory with no results found.

no results found.

VA NAC searched with key items #AFT3100, #IN110 and key word

DSBS searched with key items #AFT3100, #IN110 and key with two vendors ever being awarded contracts; Global Focus Marketing & Distribution, LTD. (UEI:

C1ZDG1ABC6R5) Small Business and Branch Medical LLC (UEI: HMAKT7YKT4L4) SDVOSB.

SAM search with Entity names; Global Focus Marketing & Distribution, LTD. (UEI: C1ZDG1ABC6R5), Branch Medical LLC (UEI: HMAKT7YKT4L4), and Immuno Concepts Inc. resulting in Global Focus Marketing (SB) and Branch Medical (SDVOSB) active / current and with OEM, Immuno Concepts Inc.

unable to find. Finally, reached out to OEM: Immuno Concepts who verified that Global Focus Marketing & Distribution, LTD. (UEI: C1ZDG1ABC6R5) a Small Business and Branch Medical LLC (UEI:

HMAKT7YKT4L4) a SDVOSB are their sole distributors. OEM does not sell direct.

Based on the outcome of the conducted Market Research, the CS concludes that the VA Rule of Two is not met but did reveal that two capable SB vendors that are likely to provide a fair and reasonable price, whereby providing best value to the Government. Therefore, based on the NMR Decision Tree, the CS/CO intends to solicit this requirement as Small Business set-aside meeting the SBA Rule of Two.

5. 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.

Contracting Officer: Date: