REDACTED_JA-21-05-00311_BOND RX STAINER.pdf

Control Number: JA-21-05-00311 CUI

CUI

(Source Selection Information - See FAR 2.101 and 3.104-4)

APR 2021

Justification Review Document for Limited Source Justification

Under FAR Part 8

Program/Equipment: Leica Biosystems BOND RX Stainer

Authority: 10 United States Code 2304(c)(1)

Amount: The estimated price of the required Leica Biosystems BOND RX stainer is $ 300,383.03.

Leica Biosystems BOND RX Stainer, USAMRIID, Fort Detrick

Limited Source Justification

1. Contracting Activity: The contracting activity responsible for this action is the U.S.

Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, Maryland 21702-5014.

2. Description of Action: The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) requests a new firm-fixed price contract for a Bond RX Stainer with Government Scientific Source Inc. 12351 Sunrise Valley Drive, Reston, Virginia 20191. The Government projects award for May 2021 and fiscal year 2021, Research, Development, Testing and Evaluation (RDT&E), Army funds will be used.

3. Description of Supplies/Services: This action includes the purchase of Leica Biosystems BOND RX stainer with an estimated value of $300,383.03. This instrumentation will be used in the pathological evaluation of viruses, bacteria, vaccines, and therapeutics, as well as their interactions, which will facilitate the development of countermeasures against viral and bacterial bio-threat agents.

4. Authority Cited: 10 United States Code 2304(c)(1) as implemented in Federal Acquisition Regulation 8.405-6(a)(1)(i)(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.

5. Reason for Authority Cited: The proposed contractor for this action is Government Scientific Source (GSS), Inc. GSS is the sole small business distributor and the sole GSA provider for BOND RX stainer. Leica Biosystems is the sole manufacturer of BOND RX stainer, to which Leica Biosystems exclusive patent, is the only stainer combining staining automation and customization options, which addresses the Pathology Division’s need for an automation system to detect viral and bacterial antigens in a variety of different samples (including tissue and cell culture). Specifically, the BOND RX stainer provides the following unique capabilities that meet Pathology Division needs: 1) this stainer can not only be used for immunohistochemistry staining, but also can be used for RNAscope in situ hybridization (ISH) and immunofluorescence assay (IFA); and 2) the BOND RX platform provides researchers with the ability to design their own ideal protocol to meet unique and specific staining needs. These two capabilities and the applicable technology are not offered by any other competitive commercial stainers, as these are unique to Leica Biosystems.

Only Leica Biosystems BOND RX stainer (available on GSA Federal Supply Schedule contract GS-07F-5934R) meets USAMRIID below specific needs. 1.High speed (at least 30 slides/2.5 hour). 2. Customization options to allow us detect various viral and bacterial antigens with different pretreatment requirements. 3. Retain tissue integrity and morphology. 4. Compatible with current staining techniques including RNAscope ISH and Agilent/DAKO Envision IHC currently being used by USAMRIID. No other brand of commercial stainers can satisfy the Government requirement.

6. Efforts to Obtain Competition: No effort will be made to solicit offers from any other source. Leica Biosystems is the sole manufacturer of BOND RX stainer, and Government Scientific Source is the sole small business distributor and the sole GSA provider for BOND RX stainer.

a. Effective competition. The proprietary nature of the equipment being acquired cannot be replicated by other vendors.

b. Subcontracting competition. Subcontracting is not practicable given the dollar amount of this acquisition.

7. Actions to Increase Competition: USAMRIID and USAMRAA will periodically conduct market research and analysis to determine if other suppliers may be able to fulfill any future staining system acquisitions. Due to future changes in the customer’s technological requirement, more competition may occur to allow for other suppliers in the market to compete for similar requirements in the future, and such sources will be considered for award at that time.

8. Market Research: USAMRIID conducted print and internet market research for sources in FY 2021. Market research in FY 2021 has included surveys from other collaborating pathology laboratories. Market research and survey from other collaborating pathology laboratories confirmed that the BOND RX stainer by Leica Biosystems provides a superior quality automation of IHC, ISH, and IFA and endless customization options, which are not yet attainable by other suppliers.

In accordance with Defense Federal Acquisition Regulation Supplement (DFARS) 205.205-71, DFARS 206.302-1(d), and DFARS Procedures, Guidance and Information (PGI) 206.302-1(d), a request for information (RFI) was posted to SAMS.beta.Gov on 30 April 2021 for eight (8) days and as a result of the RFI no contractors showed an interest in this announcement.

9. Other Facts: N/A

a. Procurement history: N/A

b. Other facts: N/A

10. Technical Certification:

I certify 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.

11. Requirements Certification:

I certify 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.

12. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable based on price analysis.

13. Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Digitally signed by

-04'00'

Digitally signed by

Date: 2021.05.20 09:16:20 -04'00'