B01. Sole Source Justification IAW FAR 13.106 (Brand Name)_REDACTED.pdf

CUI

Control Number: FY25-0296

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

NOV 2024

Controlled by: Defense Health Agency (DHA), United States Army Medical Research Institute of Chemical Defense (USAMRICD) Controlled by: Research Support Division (RSD) CUI Category: Source Selection Limited Dissemination Control: FED Only POC: Erin O’Keefe

Sole Source Justification (SSJ) for Requirements under the Simplified Acquisition Threshold

1. Identification of the Agency and Contracting Activity: The requiring activity is the U.S.

Army Medical Research Institute of Chemical Defense (USAMRICD). The contracting activity responsible for this action is the U.S. Army Medical Research Acquisition Activity

(USAMRAA).

2. Description of Action: This is a new contract to procure 1 sputter coater.

☒ New Requirement ☒ Purchase Order ☐ Blanket Purchase Agreement (BPA) ☐ Order against BPA # ☐ Order against Multiple Award Indefinite Delivery, Indefinite Quantity (IDIQ) Contract

# Click or tap here to enter text.

☐ Order against Single Award IDIQ Contract #.

☐ Order against Federal Supply Schedule Contract #

☐ Follow-on Requirement to Contract/Order # ☐ Modification against existing Contract/Order and Modification #

Contract Type ☒ Fixed Price ☐ Time & Materials/Labor Hours ☐ Cost Reimbursable ☐ Hybrid

3. Description of Services or Supplies and Estimated Value: The purchase of 1 high vacuum sputter coater which is used for producing very thin, fine-grained metal and carbon layers, for electron microscopy. In addition to the delivery of this system, the requiring activity is purchasing installation and one-day user training for three (3) Government civilians. The estimated value, type of funds and required delivery date are:

Period Required Delivery Date Estimated Value Type of Funding

N/A 10/07/2025 -------------- RDT&E

CUI

4. Authority:

☒ FAR 13.106-1(b)(1): For purchases not exceeding the simplified acquisition threshold, only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name, or industrial mobilization).

Or

☐ FAR 8.405-6(a)(1)(A) Urgent and compelling need exists, and following the procedures would result in unacceptable delays.

☐ 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.

☐ 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 or BPA must not have been previously issued under sole-source or limited-sources procedures.

☐ FAR 8.405-6(b)(1) Items peculiar to one manufacturer. A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer.

Or

☐ FAR 16.505(a)(4) Items Peculiar to One Manufacturer

☐ FAR 16.505(b)(2)(i)(A) The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays.

☐ FAR 16.505(b)(2)(i)(B) Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

☐ FAR 16.505(b)(2)(i)(C) The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order.

☐ FAR 16.505(b)(2)(i)(D) It is necessary to place an order to satisfy a minimum guarantee.

CUI

5. Reason for Authority Cited: The USAMRICD has a mission to discover and develop medical products and knowledge solutions against chemical threats with the vision of strengthening our nation and our world by rendering chemical threats medically harmless. Pathology involves inspection of tissues, grossly and/or via a microscope, to determine the causes and effects of diseases and chemical, biological and kinetic threats and potential therapeutics. The Research Support Division (RSD), Comparative Pathology Department (CPD) Electron Microscopy (EM) laboratory images biological samples such as those collected from experimental animal models, cultured cells or tissues, and materials such as nanoprobes. Precision sputter coating of organic or inorganic materials using coating materials such as carbon, gold/palladium, chromium, or platinum is required prior to imaging using a scanning electron microscope. Exposing uncoated biological or fragile material samples to the electron beam of a scanning electron microscope will result in irreparable physical damage to a specimen. Also, coated samples are conductive which prevents the sample from absorbing electrons during imaging and becoming charged.

Charged samples interfere with or prevent image acquisition.

CPD and RSD are an integral part of the research vision, providing support to researchers and their respective animal research protocols to study pathology associated with exposure to chemical, biological or kinetic warfare agents and a means to assess the efficacy of candidate therapeutics. One method of viewing tissue is scanning electron microscopy (SEM). Precision sputter coating of organic or inorganic materials using coating materials such as carbon, gold/palladium, chromium, or platinum is required prior to imaging using a SEM analysis. A new Sputter Coater will fully support the USAMRICD mission.

Currently the USAMRICD electron microscopy core supports four (4) funded research protocols that utilize both the transmission and scanning electron microscope. These studies are designed to characterize the ultrastructural pathology of lung tissues that result from inhalation of chemical threat agents and to assess candidate therapeutics; characterize organophosphate induced neuropathy in spinal cord and sciatic nerve tissues and candidate therapeutics; and to characterize modifications to blood glucose monitoring electrodes aimed at expanding the testing capabilities of the ChemDX field diagnostic system. Additionally, these items are categorized as ERC P = Pacing Item and such is the highest priority equipment within the Institute and is in direct support of patient care (e.g., the clinical laboratory, consultation), direct training to deploying troops, or supports a GLP study.

6. Market Research: The market research conducted centered on identifying a solution that met all Minimum Essential Characteristics (MECs) for electron microscopy sample preparation and identification of a sputter coater. The market research effort included several methods to assess the market, including utilization from the Emergency Care Research Institute (ECRI), an independent nonprofit, to identify potential sputter coater manufacturers. These initial findings were then cross-referenced against the Defense Logistics Agency Medical Electronic Catalog (ECAT) Medical Master Catalog and the General Service Administration (GSA) Federal Supply Schedules website to ascertain pricing and availability through government procurement channels.

The research also included contacting JEOL USA, Inc. for information on equipment services.

CUI

Furthermore, a review of government databases (FPDS-NG, GSA, SAM, MMC, ECAT) and Federal Service Schedule contracts was conducted to determine if existing contracts could fulfill the requirement. Finally, preferred sources like UNICOR and AbilityOne were screened for relevant products and services.

From the market research conducted, three sputter coats were identified. Each potential solution was evaluated against the specific MECs. This involved a detailed comparison of features like vacuum capability, specimen stage design (removable planets, clamping pins), tilt range, and material deposition capabilities.

Rave Scientific sells the Safematic CCU-010 high vacuum sputter coater manufactured in Switzerland. The Safematic CCU-010 does not meet the Minimum Essential Characteristics (MECs) because the planets of the planetary stage are not removable, each have only a single pin and are inset. Multiple clamping pins increase stability of the specimen stubs for coating and offer many options for angle and placement onto the surface of the specimen mount. For the most commonly used 10mm or 24mm diameter puck style specimen stubs would be mounted for coating using either clamping mounts, adhesive tape or paste. The stage diameter will permit use of adhesive tape or adhesive paste to mount the full face of a 24mm diameter puck style specimen mount flush against the planet. With inset, non-removable planets, the specimen cannot mount flush against the stage.

Also, although the tilt is close to the required MECs (45° rather than 50°), the highest possible tilt angle is necessary when coating biological samples that have highly variable surface topography, porosity and height. The ability to coat specimens at the highest possible tilt angle will increase the surface area that is appropriately prepared for imaging in the scanning electron microscope. Because of these reasons, the Safematic CCU-010 does not meet the MECs of the requirement.

Leica Microsystems sells two sputter coaters: the EM ACE200 and the EM ACE600. The EM ACE200 does not meet the MECs because it is a low vacuum sputter coater and cannot reach 2X10- 6 mbar. A high vacuum sputter coater is necessary as it allows for thinner film deposition, multi-layer deposition, and a broader range of materials to coat the samples. The Leica Microsystem EM ACE600 meets all the MECs.

The conclusion was reached only after this rigorous evaluation of available options against the defined performance requirements, revealing that only the Leica Microsystems EM ACE600 fully met the USAMRICD's needs.

7. Other Facts:

a. Procurement History:

(1) Is this a new requirement? Yes.

(2) If 6.a.(1) is No, was the action just prior to this one competed? No.

(3) If 6.a.(2) is Yes, what has changed where this action cannot be competed? The action can be competed amongst vendors capable of providing the brand name product. As described above from the market research, only the Leica EM ACE600

CUI

sputter coater meets all needs. Market research indicates two (2) vendors as suppliers for this equipment: Leica Microsystems and Thomas Scientific LLC.

b. Additional Information: Components of the EM ACE600 were identified on GSA

Advantage; however, these listings lacked essential elements such as installation, training, and necessary targets. The absence of a complete, functional solution through preferred procurement channels reinforces the requirement for a direct, sole source acquisition.

8. Technical Certification: I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Signed

Laboratory Manager, USAMRICD

9. Requirements Certification: I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Laboratory Manager, USAMRICD

10. Fair and Reasonable Cost Determination: I hereby determine the anticipated cost to the Government for this contract action will be fair and reasonable.

Basis for Determination: The prices will be found fair and reasonable in accordance with FAR 13.106- 3(a)((2)(ii) Comparison of prices found reasonable on previous purchases and FAR 13.106-3(a)(2)(iii) Current price list.

SIGNED

Erin Maddox Contracting Officer Office

**Signatures on next page **

CUI

11. Contracting Officer Determination: I certify this justification is accurate and complete to the best of my knowledge and belief.

Erin Maddox Contracting Officer Office